Regulator May Go OTC To Tackle Issue Of Drug Overdose

NEW DELHI, 7 OCT 2019:

You should soon be able to walk into your local grocery store and buy a customized dose pack of medicines for common ailments such as cough, cold or flu. India’s drug regulatory authority is mulling a proposal to introduce a properly sized “unit dose packaging” for nonprescription drugs, thereby eliminating the possibility of misuse or overdose of medicines.

A subcommittee of experts formed to look into the issue of over-the-counter (OTC) drugs in India has recommended “adequate labeling” so that consumers can “self-diagnose,” “self-elect,” “selfadminister” and “know when to stop using.” ET has reviewed the report. The experts have recommended such packaging for drugs that can be sold “without prescription, have a proven safety profile, therapeutic index and (are) used for common ailments.”

While recommending two separate categories for OTC drugs — one for those that can be sold in retail outlets and the second under the supervision of registered pharmacists — the experts suggested “labelling requirements” for OTC drugs to supersede the existing provisions.

The recommendations on labelling, if accepted, propose that all OTC drugs should have “generic name, brand name of the formulation, composition, number of doses in the saleable pack, logo signifying OTC drug or OTC drug to be prescribed under the counselling of registered pharmacist, patient information leaflet, toll free number to receive consumer complaints, among the other requirements,” according to the report.

For OTC drugs that need to be prescribed by a registered pharmacist, it has suggested that the permission for marketing may only be granted after the company provides details on “pack size, indications, patient information leaflet, safety warnings and contraindications, treatment in case of overdose,” according to one of the persons aware of the matter.

India doesn’t currently have a definition for OTC drugs. The subcommittee has recommended that a formulation should be marketed for a period of at least four years prior to the date of the application for declaring it as an OTC drug.

A drug consultative committee meeting (DCC) on September 12 decided that OTC drugs should be classified and shortlisted under two separate categories — OTC1 and OTC2. Experts such as physicians, clinical specialists, pharmacologists and pharmacists will examine each formulation and recommend categorisation.

Proposal to Let Cos Advertise

“At present there are several drugs which are neither OTC nor prescription drugs. Such drugs should be examined for classifying under suitable category,” said an official.

Commonly used medicines for cough, cold and flu as well as contraceptive pills and analgesics such as paracetamol fall under the OTC category. “The new system, if approved and implemented, will help stem misuse and overuse of common medicines,” said an official.

RC Juneja, chairman of Mankind Pharma, endorsed the proposal. “It’s a good move, only if implemented well. It will end the problem of over medication.”

As per the Nicholas Hall 2017 report, the Indian OTC market is expected to grow at a compounded annual growth rate (CAGR) of 9% to cross the $6.5 billion mark by 2026.

The experts have also suggested that manufacturers be allowed to advertise their products, after getting clearance from the Advertisement Standards Council of India. The Drugs and Magic Remedies Act, 1954 and Schedule J of the Drugs and Cosmetics Rules, 1945 restrict the advertisement of drugs to a certain extent. ET Healthworld