Policy Change Soon for Over-the-counter Drugs to Check Antibiotic Misuse in Country

New Delhi: The sale of over-the-counter (OTC) drugs in India will finally fall under a regulatory framework, with a check on quality control, advertisements and pricing.

This was decided at a special meeting of the Drugs Consultative Committee held on August 20. News18 is in possession of the minutes of the meeting chaired by the Drugs Controller General of India VG Somani and based on recommendations submitted by the sub-committee of drugs under chairmanship of NK Ahoja, Drugs Controller Haryana.

The decision has now been taken to define OTC drugs and to lay down specific provisions for their regulation. The need is to “promote self-care without compromising patient safety thereby reducing the treatment cost” and that is the underlying message in the recommendations.

Some of the recommendations suggested are as follows:

- The definition for OTC drug must be laid down in the Drugs & Cosmetics Rules, 1945

- The basic characteristics of OTC drugs should be incorporated

- The classification of OTC drugs into OTC-1 and OTC-2 based on the extent of evidence of safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism, socioeconomic conditions of the country

- An initial list of OTC drugs should be prepared

- The regulation of switch of prescription drugs to OTC drugs

- The regulation of new OTC drug approval

- The distribution and sale of OTC drugs

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The immediate consequence of this would be on the sale of antibiotics, which are often sold as OTC drugs in the absence of regulation on such drugs. According to a survey conducted by the World Health Organization (WHO) in 2015 in India, 75% of respondents suffer from the wrong notions that cold and flu can be treated with antibiotics and only 58% know they should stop taking antibiotics only when they have finished the course. A study published by the Indian Council of Medical Research (ICMR) has found antibiotic resistant organisms in the digestive tracts of two out of every three healthy persons that it tested, pointing to a rapid spread of antibiotic resistance in the Indian population.

India does not have a well-defined legal and policy framework to support and regulate the distribution, marketing and consumption of OTC drugs. This will change once the recommendations are incorporated.