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 are as follows: 1. The medicine should be approved/licensed in India 2. The medicine should be useful in a 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. 7. When more than one medicines 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 and cost-effectiveness. 8. Price of total treatment to be considered and not the unit price of a medicine. 9. 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. 10. 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 are 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 a 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 favorable 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 Stent Position • Stents and other devices are medicines and included in the Drugs and Cosmetics Act. • Stents have been put under NLEM and hence are an essential item and underprice capping. • Stents use drugs like sirolimus, everolimus, paclitaxel and zotarolimus • Each drug is different • Therefore, one category of each drug stent has to be in NLEM the one which is best suited • Only non-inferior latest stents of the same company with one best suited NLEM stent can be in non NLEM category • 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. • Some polymers are biodegradable, bio-absorbable, or bio-erodible. 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-re-stenotic 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. How to choose a stent • Stents are characterized according to material composition, thickness of struts, and whether or not they are capable of eluting drugs for local delivery • Stent design may also be specific for certain indications such as small (<2.5 mm diameter) vessels or lesions involving a bifurcation of a main vessel and side branch. Vessels smaller than 2 mm are not suitable for stenting. • Tortuous, angulated, and calcified arterial segments pose challenges for even the newest stent designs because of difficulty delivering the stent to the target lesion. • The first two DES, called first generation stents, approved were sirolimus -eluting stent (SES) in 2003 and paclitaxel -eluting stent (PES) in 2004. • In 2008, the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES), called second generation stents, were approved. • EES and Resolute zotarolimus-eluting stent (R-ZES) are comparable in terms of efficacy and safety • Use newer generation DES in almost all cases, and either EES or R-ZES are preferred choices. For patients undergoing intracoronary stenting with a DES, IMA recommends an EES, either with a durable or bioresorbable polymer or R-ZES rather than a PES. • The choice between EES or R-ZES should be guided by issues such as cost, practitioner familiarity, and availability. • There have been two iterations of the ZES (Endeavor and Resolute); manufacturing of the older Endeavor-ZES has stopped internationally. • EES may have the lowest rate of stent thrombosis than all other DES, but one cannot make a recommendation to prefer EES to R-ZES based on this factor alone. • The results of the multicenter randomized ABSORB II study by Patrick Serruys and colleagues1published in The Lancet (Nov 19, p 2479) did not show non-inferiority in terms of late luminal loss (restenosis) or superiority in vasomotor reactivity of the bioresorbable vascular scaffolds compared with the drug-eluting stents. • Earlier this year, the multicenter randomized NORSTENT elective percutaneous coronary intervention trial showed no significant differences between participants receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and non-fatal myocardial infarctions. • The bare-metal stent technology has evolved into the drug-eluting stent technology that has produced a marked reduction in restenosis, at a cost of longer term dual antiplatelet therapy. Clinicians are trying to achieve the utopian 0% restenosis with more expensive technologies that present new problems such as thrombosis, neoatherosclerosis, stent recoil, and much stronger medications for longer durations. The ABSORB II and NORSTENT studies challenge the typical trend of showing the new thing to be shinier and the old thing dustier than they really are. • Clinicians should reflect and use cost-effective technologies that have stood the test of time before adopting newer technologies on a large scale. Durable Polymer • Xience (V, Prime, Xpedition): Abbott Vascular: Cobalt chromium: Everolimus • Promus (Element, Premier): Boston Scientific: Platinum chromium: Everolimus • Resolute: Medtronic: Cobalt chromium: Zotarolimus Bioabsorbable polymer: SYNERGY: Boston Scientific: Platinum chromium: Everolimus Older Cypher Cordis/J&J Stainless Steel Sirolimus Taxus Boston Scientific Stainless Steel Paclitaxel Promus Boston Scientific Cobalt chromium Everolimus Bare Metal Vision Abbott Vascular Cobalt chromium VeriFLEX Boston Scientific Stainless steel REBEL Boston Scientific Platinum chromium Integrity Medtronic Cobalt chromium 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 should be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness. Stents need to be classified in different groups; in each group, one of them must be in NLEM and the rest in non NLEM. Will the cost of the procedure increase to compensate for the loss of profit in selling stents? 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 favorable safety profile and better cost-effectiveness is now available. All NLEM drugs have to be efficacious or proven safety and quality. Non-NLEM drugs should be non-inferior to the NLEM drugs. If a non-NLEM drug is superior to NLRM drug, it 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? Low end or high end stents, each will be a class. And, from each class, one drug must be in NLEM. Can hospital make profits from stents? As per NPPA clarification (20.2.2017), NPPA did not 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 for the hospitals. As per AIMED, the hospitals need to make income from procedure and compete with other hospitals and 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? No. There are many state government, NCDRC and court decisions against it. If stent companies do not sponsor conferences, then who will? Why should drugs or stent companies sponsor conferences? Either doctors must pay for the learning and contribute or the hospitals should sponsor out of their profits. The delegation fee in any specialty conference nowadays is not less than Rs 10,000/-. How does 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 lies with the DCGI and the expert committee under Technical Drug Advisory Board (DTAB). In the Anuradha Saha case, the apex court said one needs to follow the label cleared by the DCGI. The DCGI also has a PvPi program (9717776514 phone number). If the department receives any report of side effects of any device, the device can be immediately taken off the market. Till today, the very fact that Indian stents can be marketed means no adverse effects have been notified to PvPI so far. What is IMA’s stand on routine pharma drugs? Write NLEM drugs and inform the patient about the reason, if prescribing non NLEM drugs. IMA campaign is “Write CAPITAL, Write NLEM”. A large segment of the society will thus 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, nanotechnology, more tasty formulations etc. How much can a cardiologist charge for the implantation? As per MCI, the only requirement is transparency and pre-procedure declaration. As per CEA, rates will be defined by the state government in consultation with organisations including the IMA. How should a prescription for a stent be written? Example: Advised Everolimus Drug Eluting stent with stable polymer. Avoid writing simply ‘advised stent’. Dr KK Aggarwal National President IMA & HCFI

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

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 

Compulsory columns in a medical prescription

Compulsory columns in a medical prescription A prescription is an integral part of a consultation as it summarizes the instructions of the doctor to the patient. The Free Dictionary has defined a prescription as “a written directive, as for the compounding or dispensing and administration of drugs, or for other service to a particular patient” (http://medical-dictionary.thefreedictionary.com/prescription). Handing over of the prescription by the doctor to the patient marks the conclusion of every consultation, be it a new consultation or a follow up visit. A medical prescription traditionally enumerates the drugs that have been prescribed, along with directions for the patient to follow when taking the drug and the diagnosis. Some significant clinical findings may also be mentioned. There are four parts of a typical prescription • Superscription: Indicated by the sign Rx meaning recipe, take • Inscription: This is the main part of the prescription, contains the names, doses and dosage forms of drugs ordered. • Subscription: Directions for compounding of drugs • Signature: Instructs the patient about how to take the drugs prescribed and is preceded by the symbol S or Sig (signature - Latin) Noncommunicable diseases (NCDs) such as heart disease, stroke, cancer, diabetes and chronic lung disease are a major public health problem now incurring significant costs in their management. The Global Status Report on Noncommunicable Diseases 2010 by the WHO states that “NCDs are caused, to a large extent, by four behavioral risk factors that are pervasive aspects of economic transition, rapid urbanization and 21st-century lifestyles: tobacco use, unhealthy diet, insufficient physical activity and the harmful use of alcohol”. Given the alarmingly high prevalence of lifestyle diseases worldwide, including India, it’s now time to move beyond the confines of the traditional way of writing a prescription. In addition to the demographic data and drugs, a prescription should have some ‘compulsory columns’. • Hygiene • Vaccines • Addictions • Noise pollution • Standard Lifestyle • Rehabilitation: Exercise, job, vacation • Counselling: Diet, mental health, exercise • Point of Care Investigations: ECG, blood sugar, pocket spirometry, urine spot test, hemoglobin, blood counts, coagulation etc. • Noise pollution check • Air pollution check: PM 2.5, PM 10 • Important phone numbers: Police, hospitals, ambulance, fire department, emergency number (Similar to 911 in US, the single national emergency number in India is 112) Adding these components to a prescription is an intervention towards ‘preventive healthcare’, primary prevention or secondary prevention and check the rising prevalence of chronic lifestyle diseases. This way doctors can motivate their patients and support them to make healthier lifestyle choices. Dr KK Aggarwal National President IMA & HCFI

IMA So far

IMA So far Greetings from IMA HQs! Since the Team Digital IMA took over, we have achieved the following in the past 40 days: • In the PCPNDT Act, IMA is pursuing the Ministry to exclude clerical errors under Penal Provisions. • IMA is pursuing Ministry of Health to exclude single doctor establishment out of Clinical Establishment Act (CEA). • IMA has been able to pursue the Govt. of India to write to all States to enact special Laws, where absent, in their respective states to tackle violence against medical profession and medical establishments and requested their strict implementation, where present. • On IMA’s persuasion the government will recommend to Consumer Ministry to cap medical compensation. • IMA 1 Voice Satyagraha, IMA 1 Voice Solidarity day and IMA 1 Voice Action Day was a great success • IMA is in process of starting certifying IMA Clinics involving all national health programs. • IMA has finalized IMA Prayer. • Kerala State government has included noise and health as a Chapter in 8th standard syllabus on IMA’s recommendations. • On IMA’s intervention, 304-B was converted into 304-A in Pune case. • On IMA’s intervention, the 3 attempts for UG MBBS admission were shifted from retrospective to prospective. The Ministry of Tourism, Govt of India has been persuaded by IMA for the following: • Duration of e-medical visa to be 6 months, with double entry. • Attendants traveling with patients to be made eligible for e-medical visa on automatic route with a simplified online application procedure. • Hospitals to be responsible for reporting of personal details of patients to FRRO (Foreign Regional Registration Office) in lieu of present system of personal reporting. • Requirement of referral letter from local doctor may be dropped. • Visa fee for e-medical visa to be rationalized. • Concerned agencies to expedite accreditation process and issue of accreditation letters with respect to treatment at Ayurveda and Wellness centers. • Clear indication of the broad cost of various treatments readily available for the patients; hospitals should have all inclusive packages advertised within a band. • Under the purpose of visit for e-TV category, a separate check box to be included for Medical Attendant and that this could then be linked with documentation of the original applicant for the e-Medical Visa so that it could be clearly established who is coming in as the attendant. • e-Medical Visa on the basis of invitation letters from NABH-accredited hospitals. • Separate immigration counters at major international airports for e-Medical Visas • A facilitation counter for such tourists outside the immigration area under the aegis of the Ministry of Health and Family Welfare (MoHFW) and the Hospital Association with interpreters for Russian and Arabic languages. • NABH may set up such counters. The counter could also be connected to the MoT Helpline number 1363 for multi-language assistance, which is 24X7 service for tourists. • The cost of e-Medical Visa should be on par with that of the Tourist Visa. • MHA may be requested to include at least one Medical Attendant who could accompany the patient on the e- Medical Visa and that the visa application for the attendant be linked with that of the patient (e-Medical Visa applicant) The aim of every State of IMA should be to act locally and think nationally. Let’s all join hands together with IMA HQs and solve all national issues in the coming months.