Straight from the Heart: Team IMA Initiatives with MCI

Straight from the Heart: Team IMA Initiatives with MCI  

Dr KK Aggarwal
National President IMA

1.       Finalized Indian Medical Services draft suggestions to the Govt. of India passed by CWC IMA and GBM of MCI.

2.       As per MCI Ethic Regulations 8.6, professional incompetence shall be judged by peer group as per guidelines prescribed by the MCI.  But these guidelines were never made. IMA and MCI finalized these guidelines, passed by CWC IMA and GBM of MCI.

3.       In its judgment in Jacob Mathew vs State of Punjab & Anr on 5 August, 2005, the Hon’ble Supreme Court of India directed Statutory Rules or Executive Instructions incorporating certain guidelines to be framed and issued by the Government of India and/or the State Governments in consultation with the MCI regarding prosecution of doctors for offences of which criminal rashness or criminal negligence is an ingredient. MOH wrote to MCI to make a task force to make recommendations involving IMA. IMA and MCI has framed these guidelines and passed by CWC IMA and GBM of MCI.

4.       In Parmanand Kataria vs Union of India clarification in MCI General Body Meeting, it was submitted that Evidence Act should also be so amended as to provide that the Doctor's diary maintained in regular course by him in respect of the accident cases would be accepted by the courts in evidence without insisting the doctors being present to prove the same or subject himself to cross-examination/harassment for long period of time.”  MCI-IMA task force has framed these guidelines, which have been passed by CWC IMA and GBM of MCI.

5.       With regard to NEET, IMA wrote to MCI to relax the norms for age and number of attempts and the same was done

6.       The extended list of disabilities now has been accepted by MCI for MBS admissions and 5% of the seats are now reserved for the same

7.       We wrote to MCI regarding non-payment of stipends to interns in many private colleges. MCI is looking into t.

8.       MCI changed the professor: student ratio.

9.       IMA Grievance Cell wrote to MCI about two cases to expedite their enquiry process

10.    IMA offered CPR training after tragic death of Smt. Premlata on 16th November, 2017 at MCI premises.

11.    May 10: Sub: imposing the condition of Good Standing Certificate for those who are Registered with registering authorities in other countries [Any Graduate or Post Graduate from our country whenever intends to register with registering authorities for practicing modern medicine in the concerned countries, he/she is required to furnish a Good Standing Certificate for their verification issued by the Medical Council of India. This is solely to ensure that the concerned registered medical practitioner has a good track record and there is nothing against him/her, especially with reference to ethical breech and/or violates. In the same breath and vein, it is necessary that a similar condition needs to be imposed for Indian doctors who are practicing in other countries after getting registered in that country and intends to come back to India. Imposition of similar conditions would be required for Indian students getting their MBBS or equivalent course outside India and coming back for registration in India; foreigners to India and asking for temporary license to practice and also for Indian doctors seeking multiple registrations in different states.  This would mean that before they are registered or re-registered with the registering authorities in India, they will have to furnish the similar Good Standing Certificate as a condition precedent. This will serve a similar purpose as the Good Standing Certificate issued by the MCI serves in respect of Indian Doctors seeking registration to the competent registering authority practicing modern medicine in foreign countries. Hence the suggestion.  We are sure that the required decision will be taken, in this regard for the enforcement by all concerned.

12.    June 20: IMA wrote about Female Genital Mutilation and hysterectomy of mentally unstable females to maintain the women's hygiene during menstruation and avoidance of pregnancy in sexual abuse. As per IMA, doing so is violation of women's fundamental rights. IMA requested to clarify the position of MCI as regards to these two practices so that we can put it as IMA policy.

13.    MCI restarted Dr B C Roy National Awards on persistent reminders by IMA.

14.    Response from MCI: “This has reference to your email dated 22nd January, 2017, wherein you have forwarded a representation pertaining to permissible filling up of non-medical teachers in pre and para clinical departments in medical colleges under the ambit of the Medical Council of India.  

It may be noted that in the context of unavailability of the medical teachers (possessing medical qualifications) in the pre and para clinical subjects, the regulation as provided for a permissible percentage of non-medical teachers in the subject of Biochemistry up to the extent of 50% and physiology, microbiology, pharmacology up to the extent of 30% with a rider that the same shall be filled up in case the teachers with medical qualifications are not available. This by no stretch means that the said percentage is earmarked for non-medical teachers. Ideally speaking medical college should have teachers possessing medical qualifications, but as there is paucity hence the provision in the regulation.”

15.    MCI raised the issue regarding ESIC: DACP guidelines, Govt of India, has not been implemented for promotion of Assistant professors to Associate Professors in ESIC Medical Colleges, though assured in the recruitment Advertisements.

16.    IMA opposed introduction of NMC.

17.    IMA opposed NEXT exam, which MCI supported.

18.    IMA opposed and wrote to MCI not to support post BDS bridge course to MBBS.

19.    IMA support amendments to IMC act and say no to NMC. IMA drafted a study group report to this aspect.

20.    IMA won the PCPNDT act case in Delhi High Court. Matter is in Supreme Court now.

21.    Both IMA and MCI were part of Inter-Ministerial Committee formed by Ministry of Health.

22.    IMA supported the UPRN circular issued by MCI.

23.    In NATCON 2017, MCI has been given a slot by IMA to introduce UPRN (Unique Permanent Registration Number).

24.    MCI: “…proposed change of the MODE OF EXECUTION of persons awarded capital punishment from HANDING TO LETHAL INJECTION as proposed by the Law Commission. “The Ethical Committee of Medical Council of India has deliberated on the subject of the mode of execution of death sentence as prepared by the Law Commission and has come to the unanimous view that in order to uphold the highest moral and ethical values of humanity, the Death Penalty (capital punishment) should be abolished altogether in our country.”

1. “The members of the Adhoc Committee appointed by the Hon’ble Supreme Court and of the Executive Committee of the Council considered the recommendation of the Ethical Committee with regard to law panel for execution by Lethal injection and decided that this matter does not come under the purview of the Council.” However, the Ethics Committee strongly feels that the matter should be reexamined by the Executive Committee afresh and the Ethics Committee decision be placed before the General Body………….”

25.    Three attempts for UG MBBS admission were shifted from retrospective to prospective. IMA was flooded with students calls after the Central Board of Secondary Education (CBSE) said that AIPMT attempts will be included in the proposed NEET exam (UG) starting this year. IMA immediately took up the cause. I spoke to MCI and also to Dr Ketan Desai, then President World Medical Association (WMA). Immediate action was taken. The Health Ministry has now clarified that "since any new regulation takes effect prospectively, NEET-2017 shall be counted as the first attempt for this purpose irrespective of the previous attempts in AIPMT/NEET, subject to the upper age limit. CBSE has been advised to make necessary corrections in the information bulletin and on their website cbseneet.nic.in, so that any application is not rejected on this ground. Data pertaining to applications already rejected will be erased so that rejected applications can be filed afresh" (Press Information Bureau, 3.2.17) …

IMA Updates

IMA Updates • Medical Council of India (MCI) with inputs from IMA has drafted a document for Indian Medical services. The same will be placed in the next executive committee meeting of MCI. • MCI with inputs from IMA has finalized a draft for Guidelines to govern the prosecution of medical doctors for offences of which criminal rashness or criminal negligence is an ingredient. The same will be placed in the next executive committee meeting of MCI. • MCI with inputs from IMA has drafted standard medicolegal check list so that doctor’s diary may be sufficient to be taken up as an evidence (based on Pt. Parmanand Katara vs Union of India & Ors on 28 August, 1989). • MCI with inputs from IMA is in process of drafting guidelines for deciding negligence (8.6 Professional incompetence shall be judged by peer group as per guidelines prescribed by Medical Council of India). Practice changing IMA policies IMA TB Initiative: GTN • GeneXpert (sputum diagnosis) • Treat and Trace (treat with daily fixed dose combination regimen and trace all contacts) • Notify @ Nikshay Organ transplant • Mandatory required request for organ donation at death • 100% IMA members should pledge their organs / tissues after cardiac or brain death Blood Transfusion • IMA blood donation camps should only be component donation camps IMA-PMSMA: 9th of every month • Provider antenatal care to all pregnant mothers on 9th of every month, for nine months, checking for nine parameters (blood tests, urine tests, blood pressure, ultrasound, weight, vaccination, high risk stratification, arrangements for institutional delivery, lifestyle counseling [diet, rest, breathing, relaxation]) and involving the paediatrician at ninth month IMA Aao School Chale • 5th of every month lets us sensitise school children Ao Gaon/Slum Chalen: On first Sunday of the Month, let us sensitize the community and the families (Aao Ghar Ghar Chale) IMA PvPI Initiative: Call and report any adverse event, side effect of treatment at 9717776514 Physicians’ Health First: All IMA members to have their annual check-up done between 30th July and 5th September. Dr KK Aggarwal

Revisiting the Generic Drugs Controversy: The MCI Circular

Revisiting the Generic Drugs Controversy: The MCI Circular Dr KK Aggarwal National President IMA The 2016 amended clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 reads: "1.5 - Use of Generic names of drugs: Every physician SHOULD prescribe drugs with generic names legibly and preferably in capital letters and he/ she SHALL ensure that there is a rational prescription and use of drugs." MCI by a circular dated 21.04.2017 has reinstated that all the Registered Medical Practitioners under the IMC Act are to comply with the aforesaid provisions of the Regulations in its letter and spirit and has warned that any violation will attract disciplinary action by the concerned SMC/MCI. “Every physician” means all those who are registered with MCI or the State Medical Council. “Should” means discretional and not mandatory. “Prescribe drugs with generic names” means writing the chemical name of the drug. This is not synonymous with generic drugs. Remember there are two types of drugs: generic and patent drugs. If the clause meant patent drugs then doctors cannot write new-innovation drugs as they will be under patent for ten years. All new discoveries of ICMR, biotechnology department then will be out of the prescriptions. The purpose of writing generic name of the drug is to reduce prescription errors due to multiple brands of the same drug. Branded drugs are drugs sold under a trade mark within the validity of patent life by the innovator or their licensee. Generic drug is the nomenclature of a drug adopted post expiry of its patent. It does not include the word “only’. If that was written, one could not write the brand or the name of the company. Than we could not have written Jan Aushadhi drugs. It does not mean that one can write only the generic names. Also, it does not prohibit a doctor from writing the name of the company or the brand or Jan Aushadhi. “Legibly” means readable (does not mandate electronic prescription) “Preferably” means where ever possible (it is non-mandatory) “In capital letters” (pertains to the chemical name, again non-mandatory as some names may be complicated or with very long salt name) “And he/ she shall ensure that there is a rational prescription and use of drugs”, use of the word “shall” means that this part of the clause is mandatory. Only this mandatory portion of the clause, with the word ‘SHALL’ can be actionable. “that there is a rational prescription and use of drugs", the prescription shall have rationality of treatment and the drugs prescribed. As per WHO, rational use of medicines requires that “patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period, and at the lowest cost to them and their community.

IMA calls for issuing "Good Standing Certificate" to doctors

IMA calls for issuing "Good Standing Certificate" to doctors Writes to MCI in light of a recent incident to carry out probe against a doctor New Delhi, 21 May 2017: In light of a recent incident, the IMA has written to the MCI expressing its viewpoint about NRI doctors barred abroad working in India. As per the US court, the doctor has been ordered “not to practice medicine in any form within the United States or any other country". As per a recent court directive, based on news reports that an Indian-origin doctor, who has been barred from practicing by a US court, is now treating patients in Delhi and Gurgaon, the Member Secretary of Delhi State Legal Services Authority, Sanjeev Jain, was asked to verify the doctor's name and address, carry out an immediate probe, and file a report within four days. It also issued notice to the MCI to file a report on the mechanism, statutory regime as well as rules and regulations in place to scrutinize and check such practices and made the Ministry of Health and Family Welfare a party. Speaking collectively on behalf of IMA, Padma Shri Awardee Dr K K Aggarwal, National President Indian Medical Association (IMA) and President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement, said, "IMA is for a defined policy in such cases. We believe that the MCI needs to issue a 'Good Standing Certificate' to all graduates and post graduates who wish to register with registering authorities in other countries. This will serve as an indication of a good track record and also be a proof of the fact that the concerned person has committed no ethical breach and/or violation. A similar condition should also be imposed for Indian doctors practicing in other countries and wanting to come back and practice in India after getting registered in another country. This will ensure transparency and hence, lesser mishaps of the nature." At Delhi High Court, a bench of Acting Chief Justice Gita Mittal and Justice V K Rao, took a suo moto note to examine the issue on whether Indian-origin doctors, barred from practicing by a foreign country can practice in India. Adding further, Dr Aggarwal, said, "It is just a way to ensure quality of doctors is maintained. If we are asked for a certificate when we go to practice abroad then why can’t we ask for it from those who want to practice in India. We had spoken to MCI officials about this and they asked us to write to them."

Can NRI doctors barred abroad work in India? IMA writes to MCI

Can NRI doctors barred abroad work in India? IMA writes to MCI At Delhi High Court, a bench of Acting Chief Justice Gita Mittal and Justice VK Rao, took a suo moto note to examine the issue whether Indian-origin doctors, barred from practicing by a foreign country, can practice in India? Based on news reports that an Indian-origin doctor, who has been barred from practicing by a US court, is now treating patients in Delhi and Gurgaon, the court directed the member secretary of Delhi State Legal Services Authority, Sanjeev Jain, to verify the name and address of this doctor, carry out an immediate probe and file a report within four days; issued notice to the MCI to file a report on the mechanism, statutory regime as well as rules and regulations in place to scrutinize and check such practices and also made Ministry of Health and Family Welfare a party. The next date of hearing was on May 15. As per the US court, the doctor has been ordered “not practice medicine in any form within the United States or any other country" IMA Response: IMA is for a defined policy in such cases. IMA wrote to the MCI on 9th in this regard. To The President Medical Council of India New Delhi Sub: imposing the condition of Good Standing Certificate for those who are Registered with registering authorities in other countries Respected Madam Greetings from Indian Medical Association! We deem it fit to bring it to your kind notice that any Graduate or Post Graduate from our country whenever intends to register with registering authorities for practicing modern medicine in the concerned countries, he/she is required to furnish a Good Standing Certificate for their verification issued by the Medical Council of India. This is solely to ensure that the concerned registered medical practitioner has a good track record and there is nothing against him/her, especially with reference to ethical breach and/or violation. In the same breath and vein, it is necessary that a similar condition needs to be imposed for Indian doctors who are practicing in other countries after getting registered in that country and intend to come back to India. Imposition of similar conditions would be required for Indian students getting their MBBS or equivalent course outside India and coming back for registration in India; foreigners to India and asking for temporary license to practice and also for Indian doctors seeking multiple registrations in different states. This would mean that before they are registered or re-registered with the registering authorities in India, they will have to furnish the similar Good Standing Certificate as a condition precedent. This will serve the similar purpose as the Good Standing Certificate issued by the MCI serves in respect of Indian Doctors seeking registration to the competent registering authority practicing modern medicine in foreign countries. Hence the suggestion. We are sure that the required decision will be taken, in this regard for the enforcement by all concerned. With kind regards Dr KK Aggarwal National President, IMA Padma Shri Awardee Dr RN Tandon Hony Secy General, IMA

“Sorry I cannot oblige you for...”: IMA Campaign against issuance of false medical certificates

“Sorry I cannot oblige you for...”: IMA Campaign against issuance of false medical certificates Dr KK Aggarwal National President IMA & HCFI Doctors are required to issue medical certificates and/or certificate for fitness to work or resume duty. The Medical Council of India (MCI) has provided a list of certificates, reports, notifications etc. issued by doctors for the purposes of various acts / administrative requirements in Appendix 4 of its Code of Ethics Regulations, 2002: • Under the acts relating to birth, death or disposal of the dead. • Under the Acts relating to Lunacy and Mental Deficiency and under the Mental illness Act and the rules made thereunder. • Under the Vaccination Acts and the regulations made thereunder. • Under the Factory Acts and the regulations made thereunder. • Under the Education Acts. • Under the Public Health Acts and the orders made thereunder. • Under the Workmen’s Compensation Act and Persons with Disability Act. • Under the Acts and orders relating to the notification of infectious diseases. • Under the Employee’s State Insurance Act. • In connection with sick benefit insurance and friendly societies. • Under the Merchant Shipping Act. • For procuring / issuing of passports. • For excusing attendance in courts of Justice, in public services, in public offices or in ordinary employment. • In connection with Civil and Military matters. • In connection with matters under the control of Department of Pensions. • In connection with quarantine rules. • For procuring driving license. At times, they may be urged by friends, or other individuals to provide certificates with falsified information to take medical leave, claim financial benefits, compensations, etc. And, they may find it difficult to say no. The Indian Medical Association (IMA) is against issuing or obliging for false certificates. The IMA campaign in this regard “Sorry I cannot oblige you for...” is directed at learning to say no to issuing false certificates. Medical certificates are legal documents. Doctors therefore must be aware of the implications of signing a medical certificate, to themselves, the patient and the organization to which the certificate would be submitted and act according to the regulations defined by the MCI relating to the Professional Conduct, Etiquette and Ethics. Any certificate issued by a doctor not as per the requirements defined in the Regulation 1.3.3 of the MCI Code of Ethics Regulations, 2002 (as follows) is not a valid certificate: “A Registered medical practitioner shall maintain a Register of Medical Certificates giving full details of certificates issued. When issuing a medical certificate he / she shall always enter the identification marks of the patient and keep a copy of the certificate. He / She shall not omit to record the signature and/or thumb mark, address and at least one identification mark of the patient on the medical certificates or report.” In Ram Narain Gupta vs Smt. Rameshwari Gupta on 12 September, 1988 AIR 2260, 1988 SCR Supl. (2) 913, the Supreme Court of India observed: “… Neither in the first certificate (Ext. 4) nor in the second certificate (Ext. 3) … stated that the schizophrenia, the defendant is suffering from, was of the third variety, namely, Catatonia, when the patient becomes wild, destructive and violent. In this statement also … does not state that the schizophrenia was of Catatonia variety. He does not say even a word about the danger, arising from the mental disorder of the defendant. The certificate Ext. 3 does not bear the thumb impression or signature of the defendant and, therefore, it cannot be said with certainty that the said certificate was issued by … after having examined the defendant.” If you issue a false certificate, you can lose your license (permanently) to practice as per Regulation 7.7, which says “Any registered practitioner who is shown to have signed or given under his name and authority any such certificate, notification, report or document of a similar character which is untrue, misleading or improper, is liable to have his name deleted from the Register.” Issuing a false document is forgery, which is an offence liable to imprisonment under Section 468 of the Indian Penal Code and has been defined under Section 463 of the IPC. “468. Forgery for purpose of cheating: Whoever commits forgery, intending that the 1[document or electronic record forged] shall be used for the purpose of cheating, shall be punished with imprisonment of either de¬scription for a term which may extend to seven years, and shall also be liable to fine.” “463. Forgery. Whoever makes any false documents or false electronic record or part of a document or electronic record, with intent to cause damage or injury], to the public or to any person, or to support any claim or title, or to cause any person to part with property, or to enter into any express or implied contract, or with intent to commit fraud or that fraud may be committed, commits forgery.” The Delhi Medical Council has framed guidelines for issuance of medical certificate in its order DMC/DC/F.14/Comp.1107/2/2014/ dated 17th October, 2014 a. “Medical certificates are legal documents. Medical practitioners who deliberately issue a false, misleading or inaccurate certificate could face disciplinary action under the Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations, 2002. Medical practitioners may also expose themselves to civil or criminal legal action. Medical practitioners can assist their patients by displaying a notice to this effect in their waiting rooms. It is, therefore, a misnomer to state that medical certificate is “not valid for legal or Court purposes”, and should be avoided. Registered medical practitioners are legally responsible for their statements and signing a false certificate may result in a registered medical practitioner facing a charge of negligence or fraud. b. The certificate should be legible, written on the doctor’s letterhead and should not contain abbreviations or medical jargon. The certificate should be based on facts known to the doctor. The certificate may include information provided by the patient but any medical statements must be based upon the doctor’s own observations or must indicate the factual basis of those statements. The Certificate should only be issued in respect of an illness or injury observed by the doctor or reported by the patient and deemed to be true by the doctor. The certificate should: i. indicate the date on which the examination took place ii. indicate the degree of incapacity of the patient as appropriate iii. indicate the date on which the doctor considers the patient is likely to be able to return to work iv. be addressed to the party requiring the certificate as evidence of illness e.g. employer, insurer, magistrate v. indicate the date the Certificate was written and signed. vi. Name, signature, qualifications and registered number of the consulting Registered Medical Practitioner. vii. The nature and probable duration of the illness should also be specified. This certificate must be accompanied by a brief resume of the case giving the nature of the illness, its symptoms, causes and duration. When issuing a sickness certificate, doctors should consider whether or not an injured or partially incapacitated patient could return to work with altered duties. c. The medical certificate under normal circumstances, as a rule, should be prospective in nature i.e. it may specify the anticipated period of absence from duty necessitated because of the ailment of the patient. However, there may be medical conditions which enable the medical practitioner to certify that a period of illness occurred prior to the date of examination. Medical practitioners need to give careful consideration to the circumstances before issuing a certificate certifying a period of illness prior to the date of examination, particularly in relation to patients with a minor short illness which is not demonstrable on the day of examination and should add supplementary remarks, where appropriate, to explain the circumstances which warranted the issuances of certificate retrospective in nature. d. It is further observed that under no circumstances, a medical certificate should certify period of absence from duty, for a duration of more than 15 days. In case the medical condition of the patient is of such a nature that it may require further absence from duty, then in such case a fresh medical certificate may be issued. e. Record of issuing medical certificate -Documentation should include : • Patient to put signature / thumb impression on the medical certificate • Identification marks to be mentioned on medical certificate • that a medical certificate has been issued • the date / time range covered by the medical certificate • the level of incapacity (i.e. unfit for work, light duties, etc. within scope of practice) An official serially numbered certificate should be utilized. The original medical certificate is given to the patient to provide the documentary evidence for the employer. The duplicate copy will remain in the Medical Certificate book for records. The records of medical certificate are to be retained with the doctor for a period of 3 years from the date of issue.”

IMA White Paper on Stent Controversy

IMA White Paper on Stent Controversy Report of the Core-Committee for Revision of National List of Essential Medicines November 2015 A Core-Committee was constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India, under the chairmanship of Dr VM Katoch, the then Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR), and Dr YK Gupta, Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS) as the Vice Chairman. The Core-Committee in its initial meetings deliberated and decided on the criteria for inclusion and deletion of medicines in National List of Essential Medicines (NLEM). The criteria for inclusion of a medicine in NLEM 1. The medicine should be approved/licensed in India 2. The medicine should be useful in disease which is a public health problem in India. 3. The medicine should have proven efficacy and safety profile based on valid scientific evidence. 4. The medicine should be cost effective. 5. The medicine should be aligned with the current treatment guidelines for the disease. 6. The medicine should be stable under the storage conditions in India. When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness. 7. Price of total treatment to be considered and not the unit price of a medicine. 8. Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance. 9. The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels. The criteria for deletion of a medicine from NLEM is as follows 1. The medicine has been banned in India. 2. There are reports of concerns on the safety profile of a medicine. 3. A medicine with better efficacy or favorable safety profiles and better cost-effectiveness is now available. 4. The disease burden for which a medicine is indicated is no longer a national health concern in India. 5. In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Indian context. The Core-Committee in its first two meetings, discussed in detail the modalities to be followed for revision of NLEM and prepared guiding principles and criteria for the revision of NLEM 2011 as under Criteria for Inclusion of a Medicine into NLEM 2015 For inclusion of a medicine into NLEM, the medicine should: 1. Be licensed/ approved in the country by Drugs Controller General (India) 2. Be useful in disease which is a public health problem in India 3. Have proven efficacy and safety profile based on valid scientific evidence 4. Be comparatively cost effective 5. Be aligned with the current treatment guidelines for the disease 6. Be stable under the storage conditions in India Medicines recommended under National Health Programmes of India are considered for inclusion in NLEM. In addition, the following criteria were also considered: 1. When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost effectiveness. 2. Price of total treatment to be considered and not the unit price of a medicine 3. FDC are not included unless the combination has unequivocally proven advantage over single compounds administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance 4. The medicine in NLEM will be based at P/S/T level of health care according to treatment facilities and training, experience and availability of health care personnel at these levels Criteria for Deletion of a Medicine A medicine will be deleted from NLEM 2011 in the following conditions: 1. The medicine has been banned in India. 2. If there are reports of concerns on the safety profile of a medicine 3. If medicine with better efficacy or favourable safety profile and better cost-effectiveness is now available 4. The disease burden for which a medicine is indicated is no longer a national health concern 5. In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective DISCUSSION 1. Stents are medicines and included in the drug and cosmetic act 2. Stents have been put under NLIM and hence an essential item and under prise capping 3. All stents cannot be under the same category of drug 4. Stents uses drugs like sirolimus, everolimus, pacitaxil . zotarolimus 5. Most stents are built on a stainless-steel platform, the least-expensive stent material available. Unfortunately, stainless steel is not fully compatible with the human body and implantation usually is followed closely by restenosis and thrombosis. In addition, stainless steel can pose difficulties related to some types of imaging, such as magnetic resonance. Now alternative platform materials such as gold, titanium, cobalt-chromium alloy, tantalum alloy, nitinol and several types of polymers [Silicone, polyethylene and polyurethane] are available. 6. Some polymers are biodegradable, bio-absorbable, or bio-erodible. Â Biodegradable or bio-absorbable stents contain a major component (such as an enzyme or microbe) that degrades quickly enough to make them appropriate for short-term uses. A bio-erodible polymer is a water-insoluble polymer that has been converted into a water-soluble material. Biodegradable materials can form an effective stent coating because they can be mixed with an anti-restinotic drug and will degrade within a few weeks, thus releasing the drug into the surrounding tissue and reducing the risk of restenosis. Examples of biodegradable polymers are: polyesters, polyorthoesters and polyanhydrides. Collagen is also very biocompatible and reduces the rate of restenosis and thrombosis. In addition, anticoagulants and fibrinolytic agents bound to the collagen can aid in drug delivery. Issues Can all stents be under NLEM? No. As per NLEM guidelines when more than one medicine is available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost effectiveness. Stents needs to be classified in different groups and in each group one of them must be in NLEM and the rest in non NLEM. Will the cost of procedure increase to compensate for the loss of profit in stents selling? No: As per NLEM guidelines the price of total treatment to be considered and not the unit price of a medicine Are non NLEM stents superior to NLEM stents? No. As per NLEM guidelines a drug will be deleted from NLEM if there are reports of concerns on the safety profile of a medicine and if a drug with better efficacy or favourable safety profile and better cost-effectiveness is now available. All NLEM drugs has to be efficacious or proves safety and quality. NON NLEM should be non- inferior to the NLEM drugs. If a non NLEM drug is superior to NLRM drug is likely to enter into NLEM category. Does costly means better? NLEM drugs will be cheaper and NON NLEM though costly will be non-inferior to NLEM drugs. What do you mean by high end stents? Weather low end or high end each will be a class. From each class one drug must be in NLEM. Can hospital make profits from stents? As per NPPA clarification today: NPPA didn't take price to hospitals(PTH) as price to retailers(PTR) & considered hospitals out of stents 'trade channel' for price fixing. That means there will be margins for the distributors but not fort the hospitals. As per AIMED the hospitals need to make income from procedure and compete with other hospitals & not from medical devices used in the procedure. Once hospitals won't make profits on Stents their procurement will shift back to the buying price of product and quality. Can hospitals compel a patient to buy a drug only from hospital inventory? A: No. There are many state government. NCDRC and cost decision against it. If stent companies do not sponsor the conference who will? A: Why should drugs or stent companies sponsor conferences. Either the doctors must pay for the learning and contribute or the hospitals should sponsor out of their profits. Now a days in any way no speciality conference delegation fess is less than 10,000/ How do we ensure that Indian stents are good? It is not our job to decide good or bad. Any stent approved by DCGI is good. The responsibility is on the DCGI and the expert committee under Technical drug advisory committee. In the Anuradha Saha Supreme Court case the apex court said one need to follow the label cleared by the DCGI. Also the DCGI PvPi program (9717776514 phone number) if the department receives any report of side effects of any device the device immediately can be taken off the market. Till today the very fact India stents can be marketed means no adverse effects have been notified to PvPI so far. What is IMA stand on routine pharma drugs? Write NLEM drugs and inform the patient about the reason if writing non NLEM drugs. IMA campaign is Write CAPITAL write NLEM. With this large segment of the society will be covered with affordable health care. Those who can afford can go for newer non-superior drugs with some special advantages for example longer acting, mouth dissolvable, nano- technology, more tasty formulations etc. How much a cardiologist charge for the implantation? As per MCI only thing required is transparency and pre- procedure declaration. As per CEA, rates will be defined by the state government in consultation with organisations including the IMA. What is the latest by NPPA in stents? Its today dated 20.2.2107 Dr KK Aggarwal National President IMA and HCFI

Fruit form affects glycemic response after meals

Fruit form affects glycemic response after meals The beneficial effects of fruits and vegetables on health are well-established. Reiterating this, a new study from Singapore published February 15, 2017 in the Journal of Nutrition Health and Aging, the journal of the European Union Geriatric Medicine Society says that fruits are a valuable source of nutrient regardless of the form of delivery in elderly and young adults. The study evaluated the effect of two fruits, guava and papaya in two different forms i.e. bite size and puree on glycemic response (GR) in 19 healthy participants comprising of nine elderly and 10 young adults. The study subjects consumed glucose (reference food) on three occasions and test fruits (guava bites, guava puree, papaya bites, and papaya puree) on one occasion each. All fruit forms and types studied were found to be low glycemic index (GI) (guava bites: 29; papaya bites: 38; papaya puree: 42; guava puree: 47). The glycemic response was significantly greater in the elderly compared to that observed in the young participants The study concluded that fruit form influences glycemic response in the elderly and young adults; however, all fruit types and forms studied were found to be low GI. The American Heart Association (AHA) recommends filling at least half your plate with fruits and veggies in order to make it to the recommended 4-5 servings of each per day. The American Diabetes Association (ADA) also encourages patients with diabetes to choose a variety of fiber-containing foods, such as fruits, vegetables and whole grains. Fruits and vegetables contain vitamins, minerals, phytochemicals, and antioxidants and are low in calories. Those with the most color – dark green, red, yellow, and orange – have the most nutrients. All seven colors and six tastes should be included in diet. (Source: Journal of Nutrition Health and Aging, February 15, 2017)

Dr KK Aggarwal
National President IMA & HCFI

Ozone-related premature mortality highest in India

Ozone-related premature mortality highest in India Air pollution has been under spotlight for quite some time now. Air quality in Delhi, in particular, has often been in the ‘poor’ or ‘very poor’ category since Diwali last year. Environmental pollution adds to the global burden of disease, both morbidity and mortality. High air pollution levels have been implicated in many diseases including respiratory disease, diabetes and heart disease. Air Quality Index (AQI) takes into account eight air pollutants: PM10, PM2.5, nitrogen dioxide (NO2), sulphur dioxide (SO2), Ozone (O3), Lead (Pb), Ammonia (NH3), carbon monoxide (CO). There are six AQI categories: Good (0-50), Satisfactory (51-100), Moderately polluted (101–200), Poor (201–300), Very Poor (301–400) and Severe (401-500). A new report ‘State of Global Air 2017’ released by the Health Effects Institute (HEI) and Institute for Health Metrics and Evaluation (IHME) last week states that 92% of the world’s population lives in areas with unhealthy air. All told, long-term exposure to fine particulate matter-- the most significant element of air pollution-- contributed to 4.2 million premature deaths and to a loss of 103 million healthy years of life in 2015, making air pollution the 5th highest cause of death among all health risks, including smoking, diet, and high blood pressure. As per the report, India along with China accounted for more than half of the total global attributable deaths. This report also highlighted ozone-related mortality. Globally there was a 60% increase in ozone-attributable deaths, with a striking 67% of this increase occurring in India. An estimated 2.54 lakh deaths were attributable to exposure to ozone and its impact on chronic lung disease. India recorded the highest number of premature deaths due to ozone pollution (107,800), its toll 13 times higher than Bangladesh (7900) and 21 times higher than Pakistan (5000). This report quantified air pollution using two main pollutants: PM2.5 and ozone. Surface or ground ozone is harmful, unlike the ozone layer high up in the atmosphere, which acts as a shield and protects from harmful UV rays. Ground ozone is formed by the reaction of pollutants in the vehicular and industrial emissions with sunlight. Nitrogen oxides (NOx) and volatile organic compounds (VOC) are the ozone precursors. Traffic emissions constitute more than 50% of the ozone precursors. While this report defined ozone-related deaths in numbers, it did not clarify as to how these deaths were confirmed to be due to ozone. Also, paradoxically, the levels of ozone are higher in rural areas compared to urban areas. This is because the levels of NOx are lower in rural areas. Cities have a higher NOx levels due to traffic, which neutralize ozone and keep it in or near permissible limits. Levels of PM2.5 are higher in cities. Ozone is associated with respiratory disease independent of exposure to PM2.5. Dr KK Aggarwal National President IMA and HCFI

A fasting diet reduces risk of chronic diseases

A fasting diet reduces risk of chronic diseases A randomized phase II clinical trial published in the journal Science Translational Medicine February 15, 2017 has highlighted the safety, feasibility and benefits of a ‘fasting’ diet on health by reducing the risk of cancer, heart disease, diabetes and other age-related diseases. The study conducted by researchers at the University of Southern California Leonard Davis School of Gerontology in the US evaluated the effects of a ‘fasting-mimicking’ diet (FMD) - low in calories, sugars and protein but high in unsaturated fats - on markers/risk factors associated with aging and age-related diseases such as diabetes, cancer, and cardiovascular disease in 100 generally healthy participants. The study group consumed a FMD for 5 consecutive days every month for 3 months. The control subjects were then crossed over to the FMD Group for 3 months. Body weight, BMI, total body fat, trunk fat, waist circumference, systolic and diastolic blood pressure, cholesterol, insulin‐like growth factor 1 (IGF‐1), and C-reactive protein (a marker of inflammation) were significantly reduced, particularly in individuals at risk for diseases, while relative lean body mass (muscle and bone mass) was increased. Fasting is not just abstaining from intake of food and water. Fasting also means avoiding negative thoughts. A ‘fast’ or ‘vrata’ purifies the mind, body and soul. It facilitates restraining of the senses and advocates a satvik lifestyle i.e. living a life full of satwa with devotion and discipline and avoiding rajsik and tamsik lifestyle. Our ancestors made it a compulsory practice to observe fasts, which primarily meant abstaining from eating carbohydrates once a week, and during season's change i.e. during the time of Navratras thereby preventing lifestyle diseases. Fasting helps deplete the stores of sugar in your liver. Fasting once a day in a week gives the body a much-needed rest and time to catch up on the process of repair and/or cleaning. There is nothing better than fasting once a week to keep your heart healthy…

Do CPR for 30 mins before transporting cardiac arrest victims to hospital

Do CPR for 30 mins before transporting cardiac arrest victims to hospital Quite often we read about people collapsing due to a cardiac arrest. Former President APJ Abdul Kalam collapsed while he was addressing students in Shillong. He was immediately rushed to the hospital but could not be revived. More recently, Mr E Ahamed, a Member of Parliament collapsed in the Parliament after he suffered cardiac arrest and passed away. Such instances bring CPR or cardiopulmonary resuscitation back into the spotlight. The first instinct is to immediately rush a person to the hospital when you see somebody collapse suddenly. But at times, a first responder CPR may help revive the person until medical help arrives or a defibrillator is available. According to a story reported at WPRI on Thursday (Feb 16, 2017), there has been a major change in prehospital protocol policy in Rhode Island, USA for First Responders for the management of victims of cardiac arrest. “Starting March 1, as dictated by the Rhode Island Department of Health, emergency response personnel will be required to conduct 30 minutes of cardiopulmonary resuscitation, or CPR, on cardiac arrest victims before transporting them to the hospital.” The American Heart Association (AHA) has published updated Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care in October 2015 in the journal Circulation, with some updates while continuing to emphasize on the characteristics of high-quality CPR: compressing the chest at an adequate rate and depth, allowing complete chest recoil after each compression (avoid leaning on the chest between compressions), minimizing interruptions in compressions, and avoiding excessive ventilation. · The recommended chest compression rate have been updated to 100-120/ min from the earlier at least 100/min. · The recommendation for chest compression depth for adults is at least 2 inches (5 cm) but not greater than 2.4 inches (6 cm). The earlier recommendation was at least 2 inches (5 cm). · Chest compression should be started first before rescue breaths (C-A-B rather than A-B-C). The single rescuer should begin CPR with 30 chest compressions followed by 2 breaths. While these updated AHA guidelines have refrained from recommending a duration of resuscitation, it does state as follows: “While investigators can define neither an optimal duration of resuscitation before the termination of efforts nor which patients may benefit from prolonged efforts at resuscitation, extending the duration of resuscitation may be a means of improving survival in selected hospitalized patients.” The premise of a successful cardiopulmonary resuscitation (CPR) is earlier the better and longer the better. When you come across a victim of cardiac arrest, three simple rules must be followed: Call the ambulance, check if the person is breathing or has a pulse and if not, then start chest compressions and continue for at least 30 minutes till medical help arrives. Don’t stop CPR too soon …

Natural diet efficient in reducing cancer risk

 Natural diet efficient in reducing cancer risk

Adding just one serving of fruit or vegetables per 1000 calories consumed can result in a 6% reduction of risk of cancer

New Delhi, Friday February 17 2017

As per a recent study, the consumption of fresh vegetables and fruits help lower your chances of getting head, neck, breast, ovarian and pancreatic cancers. Even one additional serving of vegetables or fruits could help lower the risk of head and neck cancer. The more fruits and vegetables you can consume, the better.

In another study, broccoli and soy protein were found to protect against the more aggressive breast and ovarian cancers. When consumed together, digesting broccoli and soy forms a compound called di-indolylmethane (DIM). In lab experiments, the researchers found that DIM could affect the motility of breast and ovarian cancer cells, which could help keep cancers from spreading. Soy, acts like estrogen and is a nutritious, healthy food, and should be eaten in moderation.

Padma Shri Awardee Dr. K.K Aggarwal, National President Indian Medical Association (IMA) and President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement said that, “Those who eat six servings of fruits and vegetables per 1,000 calories have a 29% decreased risk relative to those who have 1.5 servings. In the study, after adjusting the data to account for smoking and alcohol use – known head and neck cancer risk factors – the researchers found that those who consumed the most fruits and vegetables had the lowest risk for head and neck cancers. Vegetables appeared to offer more cancer prevention than fruits alone did.”

“Diets high in animal fat and low in fibre are associated with metabolic syndrome -- a collection of conditions including abdominal obesity, elevated blood sugar and high blood pressure. A high fat diet contributes to nourish cancer cells, thus accelerating the disease’s progression. Vegetable based diet also contains several protective compounds like flavonols which are found in fruits and vegetables, such as onions, apples, berries, kale and broccoli. Evidence suggests that people who had the highest consumption of flavonols reduced their risk of pancreatic cancer by 23%. The benefit is even greater for people who smoke”, added Dr. K.K Aggarwal.

Following are some healthy diet tips:

1. Eat multiple servings of brightly colored and seasonal fruits and vegetables every day. Fill half your plate with fruit and vegetables.

2. Choose healthy fats. Use fat–free or low fat milk and/or dairy products.

3. Severely limit red meat, including beef, pork, lamb, and goat, and processed meat consumption.

4. Opt for healthier sources of protein like fish, skinless poultry, beans, and eggs.

5. Avoid partially hydrogenated fats (trans fats), present in many fast foods and packaged foods.

6. Cut down dramatically on salt.

7. At least half of your grains should be whole grains.

8. Regular exercise pares down your risk of developing some deadly problems, including heart disease, stroke, and certain types of cancer. 

Public servants cannot show gifts as income from legal sources, says SC

Public servants cannot show gifts as income from legal sources, says SC In its judgement pertaining to the disproportionate assets case against Smt Sasikala Natarajan, the Supreme Court of India has ruled that presents could not be counted as income from lawful sources for public servants, reported Dhananjay Mahapatra in the Times of India, February 16, 2017. The Apex Court stated “Gifts to A1 (Jayalalithaa), a public servant in the context of Sections 161 to 165A IPC now integrated into the Act are visibly illegal and forbidden by law. The endeavour to strike a distinction between “legal” and “unlawful” as sought to be made to portray gifts to constitute a lawful source of income is thus wholly misconstrued." The Bench further said, “With the advent of the 1988 Act, and inter alia consequent upon the expansion of the scope of definition of the “public servant” and the integration of Section 161 to 165A IPC in the said statute, the claim of the defence to treat the gifts offered to A1 (Jayalalithaa) on her birthday as lawful income, thus cannot receive judicial imprimatur.” The defense of the counsel for Selvi J Jayalalithaa was also rejected by the Apex Court, which held that "To reiterate, disclosure of such gifts in the I-T returns of Jayalalithaa and orders of the I-T authorities on the basis thereof do not validate the said receipts to elevate the same to lawful income to repel the charge under Section 13(1)(e) of the PC Act." Accepting gifts has always posed an ethical dilemma for the doctors. They are required to maintain professional boundaries in their relationship with the patients as well as the pharmaceutical industry. Receiving gifts is one aspect of this relationship, which is fiduciary in nature. This judgement is important for doctors as it is also applicable to them, the government doctors in particular. The Medical Council of India has defined guidelines regarding this in section 6.8 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 especially in their relationship with pharmaceutical and allied health sector industry. The MCI has also defined the quantum of punishment for violation of these regulations. a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry and their sales people or representatives. • Gifts more than Rs. 1,000/- upto Rs. 5,000/- : Censure • Gifts more than Rs. 5,000/- upto Rs. 10,000/-: Removal from Indian Medical Register or State Medical Register for 3 months. • Gifts more than Rs. 10,000/- to Rs. 50,000/- : Removal from Indian Medical Register or State Medical Register for 6 months. • Gifts more than Rs. 50,000/- to Rs. 1,00,000/- : Removal from Indian Medical Register or State Medical Register for 1 (one) year. • Gifts more than Rs. 1,00,000/-: Removal for a period of more than 1 year from Indian Medical Register or State Medical Register. b) Travel facilities: A medical practitioner shall not accept any travel Facility inside the country or outside, including rail, road, air, ship, cruise tickets, paid vacation, etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME Programme, etc. as a delegate. • Expenses for travel facilities more than Rs. 1,000/- upto Rs. 5,000/-: Censure • Expenses for travel facilities more than Rs. 5,000/- upto Rs. 10,000/-: Removal from Indian Medical Register or State Medical Register for 3 months. • Expenses for travel facilities more than Rs. 10,000/- to Rs. 50,000/-: Removal from Indian Medical Register or State medical Register for 6 months. • Expenses for travel facilities more than more than Rs. 50,000/- to Rs. 1,00,000/-: Removal from Indian Medical Register or State Medical Register for 1 year. • Expenses for travel facilities more than Rs. 1,00,000/-: Removal for a period of more than 1 year from Indian Medical Register or State Medical Register. c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext. • Expenses for Hospitality more than Rs. 1,000/- upto Rs. 5,000/-: Censure • Expenses for Hospitality more than Rs. 5,000/- upto Rs. 10,000/-: Removal from Indian Medical Register or State Medical Register for 3 months. • Expenses for Hospitality more than Rs. 10,000/- to Rs. 50,000/-: Removal from Indian Medical Register or State medical Register for 6 months. • Expenses for Hospitality more than more than Rs. 50,000/- to Rs. 1,00,000/: Removal from Indian Medical Register or State Medical Register for 1 year. • Expenses for Hospitality more than Rs. 1,00,000/-: Removal for a period of more than 1 year from Indian Medical Register or State Medical Register d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed. • Cash or monetary grants more than Rs. 1,000/- upto Rs. 5,000/-: Censure • Cash or monetary grants more than Rs. 5,000/- upto Rs. 10,000/-: Removal from Indian Medical Register or State Medical Register for 3 months. • Cash or monetary grants more than Rs. 10,000/- to Rs. 50,000/-: Removal from Indian Medical Register or State Medical Register for 6 months. • Cash or monetary grants more than more than Rs. 50,000/- to Rs. 1,00,000/-: Removal from Indian Medical Register or State Medical Register for 1 year. • Cash or monetary grants more than Rs. 1,00,000/-: Removal for a period of more than 1 year from Indian Medical Register or State Medical Register. e) Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:- (i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities. (ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies. (iii) Ensure that it fulfils all the legal requirements prescribed for medical research. (iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself. (v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s). (vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way. (vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment. First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register for a period depending upon the violation of the clause. f) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his / her own professional autonomy and / or with the autonomy and freedom of the medical institution. First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register. g) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always: (i) Ensure that his professional integrity and freedom are maintained. (ii) Ensure that patients interest are not compromised in any way. (iii) Ensure that such affiliations are within the law. (iv) Ensure that such affiliations / employments are fully transparent and disclosed First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register for a period depending upon the violaton of the clause h) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publically. Any study conducted on the efficacy or otherwise of such products shall be presented to and / or through appropriate scientific bodies or published in appropriate scientific journals in a proper way” First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register Dr KK Aggarwal National President IMA and HCFI

Sameer Malik Heart Care Foundation of India an initiative by the Heart Care Foundation of India, celebrates its third anniversary

Sameer Malik Heart Care Foundation of India an initiative by the Heart Care Foundation of India, celebrates its third anniversary 

Marking the Sameer Malik Memorial Day, over 1000 beneficiaries of the fund come together with their families. New Delhi, February 16, 2017: Sameer Malik Heart Care Foundation Fund – an initiative by the Heart Care Foundation of India, a leading national non-profit organization committed to making India a healthier and disease free nation today celebrated its third anniversary. The Sameer Malik Memorial day saw over 1000beneficiaries of the fund coming together with their families for a lecture by the NGO’s president Dr. K K Aggarwal along with check-ups, consultations and recreational activities. Sameer Malik Heart Care Foundation Fund was launched three years ago with the basic ideology that no person should die of a heart disease just because of their economical background. Any person suffering from heart disease, in need of surgical intervention and cannot otherwise afford treatment can apply for the benefits of the fund by calling the helpline number +919958771177. Once shortlisted, the surgeries are performed at leading hospitals including Medanta – the Medicity and National Heart Institute. The foundation has sponsored over 500 such pro-bono surgeries till date and over 1000 patients belonging to economically weaker sections of the society have already been helped and treated. Speaking on the occasion, Padma Shri Awardee, President Heart Care Foundation of India and National President Indian Medical Association (IMA), Dr K K Aggarwal and Dr RN Tandon – Honorary Secretary General IMA said in a joint,“Women are not diagnosed or treated for heart disease as aggressively as men. Despite the fact that more women die of heart disease each year than men, they receive only 33% of all angioplasties, stents and bypass surgeries; 28% of implantable defibrillators and 36% of open–heart surgeries. Congenital heart disorders in specifically in girl children are also often left untreated until much later increasing the risk of diability and mortality. With this background, our focus in the previous year has been in helping more and more women and young children.We believe that through mass awareness, timely intervention and financial support, majority of the heart diseases can be prevented and cured. We have successfully saved over 1000 lives through the Sameer Malik Heart Care Foundation of India and continue to do so in the future. We thank the Malik family for all their support.” Addressing the press Chief Guest for the occasion, Mr. Najeeb Jung, Former Lieutenant Governor of Delhi, said, “I heartily congratulate the Heart Care Foundation of India for their relentless work in the healthcare field. The right to life, afforded by our Constitution is only possible when one is healthy, in the truest sense. India is currently booming, however, major epidemics and health crises lie in waiting and can only be averted by collaborative efforts in helping those in utmost need and raising preventive healthcare awareness.” Adding to this, Guests of honor, Mr. B.S. Bassi, Member, Union Public Service Commission (UPSC), Former Commissioner of Police Delhi and Syed Asif Ibrahim, Former Director Intelligence Bureau in a joint statement said, “Any advancement in the field of medicine is obsolete if its benefits do not permeate to those who need it the most. In a developing country like India many patients, especially from the underprivileged section of the society suffer, as they lack sufficient access to quality healthcare facilities. Women and children are the sections that suffer the most in this context. We are happy to see the efforts being put in by HCFI to ensure quality and affordable healthcare for all.” Mr. Deep Malik from the Malik family in his statement said, “I congratulate Dr KK Aggarwal and HCFI on their efforts to helping keep my brother Sameer Malik’s legacy alive through every life saved. With the increasing incidence of lifestyle diseases specially amongst a younger population, it is important to raise mass level awareness about the evils of eating junk food, smoking and drinking. We pledge our support to the NGO and will continue to support this initiative.” The helpline number +919958771177 for the Sameer Malik Heart Care Foundation Fund is open from Monday to Saturday from 9 AM to 5 PM. Individuals who wish to apply online can download the application form from the website, http://heartcarefoundationfund.heartcarefoundation.org/. An expert committee comprising of notable individuals would assess all applications received by the fund. Once sanctioned, the funds would be directly deposited in the bank account of the medical establishments treating the patient.

The eight-year cycle of Chanakya

The eight-year cycle of Chanakya Chanakya in his neeti wrote that the cycle of corruption does not last for more than eight years. He said that people who acquire money by unethical means will have to pay back to the society within eight years. Right or wrong, whether you believe in Chanakya Neeti or not it provides a good message for the youngsters in the society to follow the right path of truthfulness. Lord Krishna in Bhagavad Gita has written that everybody has to pay the price of their bad deeds or karmas sooner or later. It is the sum total of bad and good karmas, which decides the ultimate fate. Chanakya probably meant that all those who keep on earning money by unethical means and not doing simultaneously good deeds will have to suffer within eight years. The eight-year cycle is also seen in public bhedchal. Public cannot be befooled for more than eight years in a succession. The number eight is an arbitrary number and may mean six or ten years. If we look back over the years, we can see the change in public behavior every 6-10 years as far as their preference for a particular type of health wave is concerned. There was the time of Sherry Lewis weight management program which came like a storm, stayed in the market for 6-8 years and then vanished altogether. Everybody wanted to manage their weight the Sherry Lewis way. Then came the era of Personal Point, which saw a chain of weight management programs coming up and which lasting for a few more years. This was followed by weight management the Vandana Luthra way. The weight management era was followed by the era of “Reiki”. During this period all the newspapers were carried reiki advertisements and every second person in the family wanted to become a reiki master. Today no such advertisements appear in the newspapers and nobody wants to learn reiki. Then came the trend of drinking ghiya juice and doing anulom-vilom Pranayama. In spirituality, we also saw a wave of transcendental meditation by Maharishi Mahesh Yogi but the movement did not last long as he quickly realized that selling spirituality in India was not easy and it was not the right time. In terms of public behavior too, we have witnessed phases of craze for cycling, exercising, jogging, aerobic dancing, gym, western dancing, etc. From health point of view the required era is that of walking. An era where everybody from child to adult takes up walking. Medical science has shown that walking 10,000 steps a day, routine walking 60 minutes, or brisk walking 40 minutes a day (continuous or divided into four walks of 10 minutes each) are health-friendly and can reduce the burden of diseases like high blood pressure, diabetes, obesity and heart disease. Following the Vyapam scam, the Supreme Court cancelled degrees of 634 doctors for corruption in MBBS admissions in Madhya Pradesh between 2008 and 2012 and said admissions obtained through a mass fraud called "Vyapam scam" could not be condoned. The cycle of stents has also shown a reverse gear now with its coming under price control. Things, just as life, come a full circle, completing a full cycle. Dr KK Aggarwal National President IMA and HCFI

NPPA Stent Notification

NPPA Stent Notification

(Published in Part II, Section 3, Sub Section (ii) of the Gazette of India Extraordinary)

Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
National Pharmaceuticals Pricing Authority

New Delhi. The 13. February 2017

S.O. 412(E) Whereas the Government of India in the Ministry of Health and Family Welfare included Coronary Stents in the National List of Essential Medicines. 2015 (NLEM, 2015) by notification
No. X-11035/344/2015-DFQC dated 19th July 2016.

2. And whereas the Government of India in the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, by notification No. S.O. 4100 (E) dated 21st December 2016 has incorporated Coronary Stents at serial no. 31 of Schedule I of the Drug Prices Control Order, 2013 (DPCO, 2013) and therefore, Coronary Stems arc 'scheduled formulations under the provisions of the DPCO, 2013.

3. And whereas die National Pharmaceutical Pricing Authority (NPPA) was established by Resolution No. 33/7/97-PI.I dated 29. August 1997 of the Government of India in the Ministry of Chemicals and Fertilizers to fix/revise, monitor prices of drugs/formulations and oversee the implementation of the DPCO; and whereas the Government of India by S.O. 1349(E) dated 30th May 2013 in exercise of the powers conferred by Section 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955) has delegated the powers in respect of paragraphs 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 23, 24, 25, 26, 27, 28, 29,30 and 32 of the DPCO, 2013 to the NPPA to exercise the functions of the Central Government.

4. And whereas the aim of the DPC. 2013 issued under section 3 of Essential Commodities Act, 1955, is to ensure that essential drugs are available to all at affordable prices. Whereas the Hon'ble Supreme Court of India by order dated 12th November 2002 in SLP no. 3668/2003 (Union of India vs. K.S. Gopinath & others) directed the Government to ensure that life saving drugs do not fall out of price control.

5. And whereas the Core Committee which examined the issues relating to the essentiality of Coronary Stems in its report to the Government in April 2016 observed that there is very high incidence of coronary artery disease (CAD) in India associated with high morbidity and mortality; and that CAD has become a major public health problem; and that Percutaneous Coronary Intervention (PCI) procedure requiring coronary stent implantation is an important treatment modality for the management of CAD, and hence coronary stents are 'essential' for public health.

6. And whereas NPPA carried out an exhaustive exercise of consultation with stakeholders for fixing the ceiling price of Coronary Stents on 4th January 2017, 5th January 2017 and 6th January 2017, as per office memorandum no. 19(837)/2016/Div.11/DP/NPPA dated 23^rd December 2016; and whereas NPPA considered all available information and data on prices of Coronary Stents in its 40^th Authority Meeting held on 23rd January 2017. During deliberations, it was found that huge unethical markups are charged at each stage in the supply chain of Coronary Stents resulting in irrational, restrictive and exorbitant prices in a failed market system driven by information asymmetry between the patient and doctors pushing patients to financial misery; and whereas under such extraordinary circumstances, there is an urgent necessity, in public interest, to fix ceiling price of Coronary Stents to bring respite to patients.

7. And whereas the Hon’ble Supreme Court of India in its judgment in Glaxo India Limited vs UOI reported in (2014)2 SCC 753, while dealing with the implementation of notified prices for the benefit of consumers, referred to the prefatory statement made by the Hon’ble Supreme Court in Cynamide India Limited (1987) 2 SCC 722 as worth noticing, wherein the Court observed:

“2. Profiteering by itself. is evil Profiteering in the scares resources of the community, much needed life-sustaining foodstuffs and life-saving drugs is diabolic It is a menace which has to be fettered and curbed. One of the principal objectives of the Essential Commodities Act. 1955 is precisely that. It must be remembered that Article 39(b), enjoins a duty on the State towards securing 'that the ownership and control of the material resources of the community are so distributed as best to subserve the common good”.

8. And whereas the Government is under constitutional obligation to provide fair, reasonable and affordable price for Coronary Stents and therefore its immediate intervention is imperative to check unethical profiteering and exploitive pricing; and whereas Paragraph 19 of the DPCO, 2013 inter- alia authorises the Government, extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period, as it deems fit.

9. And whereas price fixation notifications issued for certain formulations under paragraph 19 of the DPCO, 2013 by the NPPA on 10th July 2014 have been upheld by the Hon'ble High Court of Bombay in its judgment dated 26th September 2016 in W.P.(C) No. 2700 of 2014 (Indian Pharmaceutical Alliance vs. Union of India) wherein the Hon'ble High Court. inter-alia, observed:

“20…… when such failure is considered in the context of role the pharmaceuticals play in the area of public health, which is a social right, the Government intervention becomes necessary especially when exploitive pricing makes medicines tin-affordable and beyond the reach of most and also puts huge financial burden in terms of out of pocket expenditure on healthcare....”

and whereas SLP (C) 30089/2016 filed by Indian Pharmaceutical Alliance has been dismissed on 24th October 2016 by the Hon’ble Supreme Court of India.

10. And whereas W.P.(C) 1772/2015 (PIL) and W.P. (C)11085/2016 have been filed in nature of Public Interest Litigation (PIL) including Cont. Case (C.) 815/2015 before the Hon’ble High Court of Delhi seeking directions to the Respondents (Union of India) to include Coronary Stents in the National List of Essential Medicines (NLEM) and thereby control the sale price of Coronary Stents.

11. And whereas, the NPPA in its Authority Meeting held on 13th February 2017, after duly examining in detail and considering all available information/data and all relevant options for price fixation of Coronary Stents, under present extraordinary circumstances of a failed and exploitative market system has decided that it is immediately necessary to fix ceding prices of Coronary stents in order to protect public interest.

12. Now, therefore, in the exercise of the powers delegated by Government of India in the Ministry of Chemicals and Fertilizers under paragraph 19 of the Drugs (Prices Control) Order. 2013 by S.O. No. 1394(E) dated 30th May 2013, the Government having been satisfied in view of extraordinary circumstances as explained above, that it is necessary to do in public interest, hereby fixes and notifies the ceiling prices, exclusive of local tax applicable, if any, in respect of Coronary Stents, as specified below:

TABLE

Sl. No.	Coronary Stents (Sl. 31 in Schedule I of DPCO, 2013	Unit (In Number)	Ceiling Price (In Rs.)
(1)	(2)	(3)	(4)
1.	Bare Metal Stents	1	7260
2.	Drug Eluting Dents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BSV), Biodegradable Stents	1	29600

Note:

(a) The ceiling prices specified in column (4) of the above table shall be applicable from the date of publication of notification in the Gazette of India Extraordinary and shall also be applicable to all the stocks of Coronary Stents available for sale in the trade channel.

(b) All manufacturers of Coronary stents, selling branded or non-branded or both versions of gents at prices higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise the price of all such stems downward not exceeding the ceiling price specified in column (4) in the above table, plus local taxes as applicable and paid, if any

(c) All manufacturers/marketers of Coronary Stents having MRP lower than the ceiling price specified in column (4) in the above table plus local taxes as applicable and paid, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.

(d) The manufactures may add local taxes/VAT and no other charges in the calculation of MRP if they have actually paid such taxes or if it is payable to the Government on the ceiling price specified in column (4) of the above said table in paragraph (12) of this order.

(e) The ceiling price for a pack of coronary stent shall be arrived at by concerned manufacturer/importer in accordance with the ceiling price specified in column (4) of the above table as per the provisions under DPCO, 2013.

(f) The manufacturers under Paragraph 24 of DPCO, 2013 shall issue price list in Form—V as prescribed in Schedule II of the DPCO, 2013 to the NPPA online through Integrated Pharmaceutical Database Management System (IPDMS) and submit a copy to all State Drug Controllers and all distributors/dealers/retailers. They shall also furnish quarterly return to the NPPA, in respect of production / import and sale of Coronary Stents in Form - III as prescribed in Schedule-II of the DPCO, 2013 through IPDMS.

(g) As per paragraph 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplement, price list, if any, as furnished by the manufacturer/importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

(h) Wherever institutions such as hospitals/nursing homes/clinics performing cardiac procedures using Coronary Stents are billing directly to the patients, they shall be required to comply with the ceiling prices notified hereinabove and follow the applicable provisions of the DPCO, 2013 including(g) above.

(i) Institutions such as hospitals/nursing homes/clinics utilizing Coronary Stents shall specifically and separately mention the cost of coronary gent along with its brand name, name of the manufacturer/importer/batch no. and other details, if any, in their billing to the patients or their representatives.

4) The ‘manufacturer’ for the purpose of this order means person who manufactures or imports or markets Coronary Stents for distribution or sale in the country.

(k) Any manufacturer or institution or person not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order. 2013 read with Essential Commodities Act, 1955.

13. The ceiling price fixed hereinabove shall be maintained for a period of one year from date of this notification, unless revised by another gazette notification.

14. Any manufacturer intending to discontinue production or import of Coronary Stents shall furnish information to the NPPA, in respect of discontinuation of production and /or import in Forrn-1V of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation as prescribed under paragraph 21(2) of the DPCO, 2013 and follow the ceiling price till clearance from the Government.

PN/I73/41/2017

F.No.8 (4I)/2017/DP/NPPA/Div II

(Dr. Sharmila Mary Joseph K)

Member Secretary,

National Pharmaceutical Pricing Authority