AIOCD up in Arms against Centre’s Move Regarding OTC Drugs

Although there is no comprehensive regulation governing the distribution, marketing, and usage of OTC drugs, the centre has recently formed a three-member committee to finalize a list of such drugs that will be available for purchase in general stores without a prescription. AIOCD opposed such a move saying that it will be counter-productive. Reports ETV Bharat's Gautam Debroy.

New Delhi : Lodging a protest over Centre’s initiative of permitting the sale of Over-The-Counter (OTC) drugs without a license in India, the All India Organization of Chemists and Druggists (AIOCD) has appealed to the Director General of Health Service (DGHS) to take all stakeholders into confidence before making regulation in this matter.

“In view of all the scientific, legal, factual and practical approaches towards this issue, it is not at all helpful to society to make available medicine in an uncontrolled environment like a general and grocery store. We All India Organisation of Chemists and Druggists and its 12.40 lakh members and association strongly stand against such an idea which is harmful to the health care system of the country,” the AIOCD wrote in a letter addressed to DGHS Dr Atul Goel.

Government initiative: The government has recently formed a three-member committee to finalize a list of OTC drugs that will be available for purchase in general stores without a prescription. This program is part of India’s new over-the-counter medicine policy, which aims to lower treatment costs and promote self-care while maintaining safety.

What is OTC drug: There is no comprehensive regulation governing the distribution, marketing, and usage of OTC drugs. Cough, cold, and contraception medications are frequently offered over the counter without proper regulation. The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 do not define over-the-counter medications.

AIOCD and its view: Established in 1975, the AIOCD is an association representing medicine traders nationwide. It has a membership of 12.40 lakh chemists across the country. According to AIOCD, OTC violates Drugs and Cosmetics Act 1940 and Rule 1945, Pharmacy Act 1948 and Pharmacy practices Regulation 2015.

Drugs and Cosmetics Act: As per Section 18 (C) of the Drugs and Cosmetics Act, if permission to sell OTC drugs is given to General and grocery stores it will violate provision of Section 18 (C) of the Drugs and Cosmetics Act. As per Section 18 (C) of the Drugs and Cosmetics Act, no person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute any drug except under licence and in accordance with the conditions of a license.

Pharmacy Act 1948 and Pharmacy Practice Regulations, 2015: As per section 42 of the Pharmacy Act 1948 dispensing of drugs by unregistered (under this Act) persons is an offense. As per this provision no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner. As per Para 4(b) of the Pharmacy Practice Regulations, 2015, a person having qualification in any other system of pharmacy is not allowed to practice the modern system of pharmacy in any form.

Violation of Supreme court directives: The Supreme Court of India in SLP 8799 of 2020 decided on November 29, 2022. Mukesh Kumar Appellant versus the State of Bihar & Ors. Respondent (S) Observed that, under the provisions of the Pharmacy Act, 1948 as well as the Pharmacy Practice Regulations, 2015, it is the duty cast upon the Pharmacy Council and the State Government to see that the hospitals/medical stores, etc., are not run by the fake pharmacist and are run by the registered pharmacist only.

“This Directives of Honourable Supreme Court of India are binding and are mandatory as per article 141 of the constitution which is self-explanatory. In view this allowing sale of even OTC drugs through general store and grocery stores is gross violation of said order and many other such orders,” AIOCD general secretary Rajiv Singhal said.

Risk of Spurious drugs: Singhal said that in the recent past many cases of spurious drugs were unearthed by various regulators including anticancer drugs. “If medicine will be available in general stores and grocery stores there will be open opportunities for antisocial elements to supply medicine as purchasers are not experts in the pharma field. This is a very serious and alarming hazard to the health care System. This will collapse the whole health care system,” he said.

Possible threats related to OTC drug: It will promote dangerous self-medication and drug abuse. It will also promote absence of pharmacist consultation services besides increasing the risk of adverse drug reactions. It will encourage proliferation of counterfeit drugs and delay access to healthcare services. It may also witness higher incidence of diseases due to medication overdose.

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