Thursday, 2 July 2015

Why should the Indian Govt. not allow online pharmacies in India?

Why should the Indian Govt. not allow online pharmacies in India?

Dr A Marthanda Pillai and Dr K K Aggarwal

An online pharmacy sounds convenient; no waiting in queues, no rushing to the pharmacy before it shuts shop for the day, placing the order is easy, moreover, the order can be placed any time of the day and the medicines are conveniently delivered via courier at your doorstep. Yet, this convenience comes at a price. Not only there may be financial implications for the patients, their safety may even be endangered at times.

The online pharmacy may have its own cancellation policy and may not refund or only partly refund the amount paid upon cancellation of the order or even non-delivery of an order. Unlike the local neighborhood pharmacy or the hospital pharmacy, the patient does not have access to a pharmacist if he/she has any questions about a medicine.

There are no well-defined dedicated laws for online pharmacies. Pharmacies in India are governed by the Drug and Cosmetics Act 1940, Drugs and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956.

Laws related to ecommerce are defined under the Information Technology Act, 2000.

According to Indian laws, a chemist can dispense prescription drugs only on the prescription of doctor. A prescription requires the name of the doctor, his /her address and registration number besides the name/s of the drug/s, their potency, dosage, and duration for which the drugs are to be supplied. The chemist cannot dispense quantity in excess of what has been prescribed by the doctor. Before dispensing the drugs, the pharmacist is expected to verify the completeness, authenticity and legality of the prescription.

Even over-the-counter (OTC) drugs can be sold only by licensed retailers.

The major issue of concern is that prescription drugs cannot be sold online. There are provisions in the various acts mentioned above regarding the same.

o According to Subsection 1 of section 42 of Indian Pharmacy Act 1948, “….no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner.” Section  42 (2) also states, “whoever contravenes the provisions of sub-section (1) shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both.”

Online availability of prescription drugs will violate provisions of various acts like Pharmacy Act, Drugs & Cosmetics Act.

o Section 10 of the Drugs & Cosmetics Act prohibits import of any drug that is not of standard quality, any misbranded, adulterated or spurious drug or any drug for requires a license for import. It also does not permit import of “any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or alleviate any disease.” Imported medicines may be fake, mislabeled and unsafe.

o Likewise, Section 18c of the Drugs & Cosmetics Act prohibits manufacture and sale of any drug without a license.

o Section 27 of Drugs and Cosmetics Act has provisions for penalty for manufacture, sale, etc., of drugs in the form of imprisonment and monetary fine. It very clearly states in subsection “b(ii) without a valid licence as required under clause (c) of section 18.”
Recently, an FIR was filed against by Maharashtra FDA for allegedly selling drugs, including prescription drugs, online for violating provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and directly contravening Section 18 (c) of the Drugs and Cosmetics Act, 1940, which prohibits manufacture and sale of certain drugs.

o The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear guidelines on the sale of Schedule H and Schedule X drugs, which are ‘restrictive drugs’ and can be sold only on the prescription of a registered medication practitioner. Schedule X drugs include narcotics and psychotropic substances. Chances of drug abuse and addiction are higher with these drugs. They also require meticulous storage and dispensing records. The prescription has to be in duplicate, one copy of which is to be retained by the licensed pharmacist for 2 years.

o Schedule H1 of the Drugs & Cosmetic Act 1945 mandates a licensed pharmacist to maintain a separate register for sale of drugs that are specified in Schedule H1 with details of the patient, doctor and the name of the drug/s including quantity; it is to be kept for three years and is open to inspection by regulatory authorities. Schedule H1 mainly includes potent antibiotics (like anti-tuberculosis drugs), habit forming painkillers like Tramadol and anti-anxiety drugs that induce sleep.

Schedule H1 drugs are also required to have special labeling, with symbol Rx in red to be clearly displayed on the left top corner of the label and a box warning with a red border - “It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a registered medical practitioner.”

Online pharmacies may not abide by these regulations and bypass them.

The objective of Schedule H1 was primarily to check the indiscriminate use of antibiotics in India, in view of the rising incidence of multi-drug resistant bacteria, a serious public health issue worldwide. Easy access to antibiotics via online pharmacies will defeat this very purpose.

o The Drugs and Cosmetics Act has no provisions for online sale of medicines, or home delivery of medicines. Hence, online sale of medicines cannot be legally permitted.

The prescriptions submitted via fax/email may be fake and it could be difficult to verify their authenticity. Online correspondence and/or scanned copies are legally not permitted.

Online pharmacies will promote drug abuse, drug misuse, self-medication etc. Any mediation taken without the supervision of doctors may be dangerous and even potentially life-threatening.

Pharmacists are not allowed to accept and dispense prescriptions that are brought in by children. Online pharmacies will provide easy access to controlled drugs or even street drugs to this vulnerable group.

Regulation 5.3 of MCI Code of Ethics stipulates that pharmacists and doctors should work together. If online pharmacies are allowed, then this relationship will be lost.

Many online pharmacies may be operating without the appropriate license. This increases the chances that drugs sold by such unlicensed pharmacies maybe counterfeit, substandard, or adulterated and therefore risky to the patient. There are no checks in place to make sure that the drugs sold by online pharmacies are not spurious.

If online pharmacies are allowed, the National Pharmacovigilance Program, initiated by Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, will become a futile exercise. This program is not only meant for doctors but also for pharmacists. In March this year, the Health Ministry approved a Materio Vigilance Programme of India to monitor adverse events associated with medical devices. If there is no system in place to monitor and analyze adverse drug reactions, this will directly affect the health of the patients.

Medicines have to be stored properly as recommended by the manufacture. Exposure of medicines to high temperatures in storage or in transit could diminish their efficacy and are a potential health risk. There is no way to check the storage conditions of the drugs sold by the online pharmacies.

Regulatory authorities continue to monitor a drug for any adverse effect even after it has been on the market. If the safety/quality of the medicine comes under question or, if it is potentially contaminated, mislabeled or is improperly packaged, then they may recall or withdraw a prescription or OTC drug from the market even after it has been approved. Sometimes, the manufacturer may voluntarily recall a drug. If online pharmacies are permitted, the drug recalls become very, very difficult, almost next to impossible.

Breach of confidentiality is another major concern. Online pharmacies may misuse personal and financial information of the patient as well as of doctors leading to cases of identity thefts and fraud.

The WMA 2005 Declaration of Lisbon on the Rights of the Patient gives them the right to confidentiality, which states that all identifiable patient data must be protected. Regulation 7.14 of MCI Code of Ethics 2002, also does not allow a registered medical practitioner to disclose the secrets of a patient that he/she may have been learnt in the exercise of his / her profession. Declaration (g) given to doctors at the time of registration states: I will respect the secrets which are confined in me.

There is no legislation specific to data privacy in India as yet. The laws that deal with data protection or privacy in India are Section 43A of the Information Technology Act, 2000 and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011.

There is a proposed Privacy (Protection) Bill, 2013 (“Bill”), which focuses on the protection of personal and sensitive personal data of persons. If passed and enacted, it will override all existing provisions directly or remotely related to privacy under section 3, which provides that “no person shall collect, store, process, disclose or otherwise handle any personal data of another person except in accordance with the provisions of this Act and any rules made thereunder.”

Online pharmacies offer drugs at low cost or at discounted prices to lure customers. If the online pharmacy gives cheaper alternatives of drug/s prescribed, this violates the doctor-patient-pharmacist relationship, which is based on trust.

Pharmacy laws in India do not allow a pharmacist to substitute a brand written by a doctor.

Pharmacists are also not authorized to change potency of the prescribed drug, even if the patient asks for it.

Refilling of a prescription is not allowed by pharmacists unless authorized by the doctor. If the doctor has prescribed a drug, e.g., 3 days, the pharmacist cannot dispense drugs for more than this duration.

Online pharmacies may provide rebates and commissions to doctors to provide prescriptions on the basis of online information that has been filled by the patient. This way doctors will be vulnerable to malpractice suits. Regulation 6.4 of MCI Code of Ethics prohibits doctors from giving or receiving any rebates or commissions.

Similar to the online search service, online pharmacies may also promote doctor substitution, which is unethical.

Ultimately online pharmacies will be taken over by MNCs and Indian laws are not applicable to MNCs.

Indian Medical Association is against online pharmacies in India. This will encourage substitution of cheaper and spurious drugs by the online stores and the doctor-patient confidentiality will be affected. And, will be a violation of all the laws quoted above. It will deny the patient the supervision of the Doctors in the use of medicines. This will encourage patient to use one prescription repeatedly without the supervision of the Doctor. This can cause many adverse drug related reactions, it will encourage drug abuse and overuse of habit-forming drugs. The medicolegal liability will still fall on the doctor, when a patient misuses this facility. The service of online pharmacy will be utilized by affluent and educated people. Hence online pharmacy has no public health benefits or implications; but at the same time it is loaded with scope for misuse, drug abuse, dependence and adverse reactions.

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