Health ministry to finalise OTC drug

India’s over-the-counter drug regulation, which has been in the works for more than four years, is likely to be out soon as the government is in the final stages of drafting it.

Addressing a webinar on “OTC Drug Regulations: Overview of Global Practices & Way forward for India” held by All India Drugs Control Officers' Confederation (AIDCOC) recently, Atul Kumar Nasa, head of Delhi Drugs Control Department, said “We are in the final stage of drafting OTC drug regulation.”

During the 52nd meeting on September 18, 2017, Drugs Consultative Committee (DCC) recommended the creation of a separate category of OTC drugs. Further, a subcommittee was set up under the chairmanship of Dr. Ravi Shankar IPS, Drugs Controller, Andhra Pradesh’ to examine drugs marketed in India vis-à-vis conditions for sale stipulated under various schedules, i.e. Schedules H, H1, G, X, and K, and recommend the list of drugs that may be considered for marketing as OTC along with conditions to be followed.

The Shankar committee submitted its report containing recommendation on definition, characteristics, classification of OTC drugs, preparation of initial list of OTC drugs, regulation of Rx drug to OTC drug switch process, regulation of new OTC drug approval, manufacturing, labelling, distribution and sale of OTC drugs, their advertisement and pricing, etc.

During 55th meeting on February 1, 2019, DCC set up a subcommittee under chairmanship of NK Ahooja, Drugs Controller, Haryana to look into the report submitted by the Shankar Committee and submit its recommendations to the DCC for further consideration.

Ahooja committee stressed on the need to define OTC drugs in the Drugs and Cosmetics Rules and lay down specific provisions for the regulation of OTC drugs and incorporate basic characteristics of OTC drugs. It recommended promotion of self-care without compromising patient safety thereby reducing treatment costs.

The committee further recommended 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, and socioeconomic conditions of the country.

Its other recommendations include preparing initial list of OTC drugs, regulating the switch of prescription drugs to OTC drugs as well as regulating new OTC drug approval and the distribution and sale of OTC drugs and their advertisements.

Based on the recommendations of the Ahooja Committee, the DCC recommended that suitable amendment should be introduced in Schedule K (exemptions and conditions for exemption from the provisions of Chapter IV of the D&C Act and the Rules made thereunder) of the D&C Rules to incorporate necessary provisions for OTC drugs for providing exemptions from requirements of prescription and/or sale licence, subject to appropriate conditions.

The DCC further recommended that the Ahooja Committee should identify the list of OTC drugs, along with conditions, and frame the draft for amending the D&C Rules.

Unlike US, European Union, Australia which have well defined OTC law, OTC drugs are not defined as a separate category of drugs in D&C Rules in India.

“We have to take utmost care while framing the OTC guidelines as these drugs may lead to self-medication,” Dr Nasa.

“Well defined regulatory framework for OTC drugs in India is need of the hour. Strong advocacy campaign for creating general public awareness regarding responsible selfcare will be helpful to serve public interest. In future, prescription to OTC switch process will be commonly used strategy for responsible selfcare to help achieve health goal of India,” said Dr Sonal Shidhore, director, regulatory affairs, Johnson and Johnson Pvt Ltd.

“In India OTC is not defined. No advertisement is allowed for scheduled drugs. OTC drugs are non-prescription drugs. It can be used by patient directly for treating minor aliments with or without medical support. Awareness of such drugs need to be created through advertisements. There is no formal switch process in D&C Act from prescription to non-prescription category,” said Dr Shidhore.

Industry-regulators dialogue is ongoing through industry associations forum. Industry is having multiple meetings with OTC subcommittee members. It provided feedback on initial list for OTC. Companies have showed willingness to take responsibility for providing safety data, justification for providing safety data, justification for inclusion as OTC, she stated.

Talking about key drivers for OTC policy implementation, she stressed for identification of molecules/FDCs for OTC switch where benefits outweigh risks, low potential misuse and abuse, acceptable margin of safety with previous use experience in India and other markets, molecule status as OTC in other markets, convenient for informed use with adequate information on label/package insert and patient awareness through advertisements.

Dr Shidhore said proposed guidance document should contain definition of advertisement. “Advertisement of OTC to be allowed in all media. Drug claims need to be consistent, non-deceptive and simple to understand and to be supported with substantiation data. Advertisement also to be used for awareness by urging consumers to read the label or patient information leaflet for more information. Advertisements must include mandatory warnings to seek a physician’s opinion if symptoms persist for specific number of days, depending on the ailment. Comparative claims may be allowed without disparaging,” she suggested.