Industry stakeholders express that there is an urgent need to define over the counter (OTC) drugs regulation in India and implement it on priority for the benefit of patients, in a recently held webinar on proposed OTC regulations, jointly organised by the OPPI, IPA and FICCI.

In fact, FICCI is in the process of making a representation to government authorities requesting them to fasten the regulatory process and review the recommendations report of a subcommittee of OTC Drug Regulations, also known as Ahooja Committee, constituted under the chairmanship of Narendra K Ahooja, Drugs Controller, Haryana.

Ahooja said, “Over the counter drug regulations are required for the following reasons:

1. To reduce the treatment cost

2. To eliminate the problem of unregistered medical practitioners, who are neither having qualification as required under Rule 2 (ee) of Drug Rules nor having qualification as prescribed under Indian Medical Council Act 1956 and the Central Council of Indian Medicine Act 1970

3. To provide primary healthcare facility to all at the doorstep up to village level

4. To empower registered pharmacists and to provide a legal base to pharmacists to perform their duties under the Pharmacy Act 1948 as provided under Chapter II Code of Pharmacy Ethics and

5. To eradicate the problem of irresponsible self-medication.

He added, “Based on the recommendations of the Sub Committee of OTC Drug regulations, the DCC had suggested that suitable amendments should be made 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 to provide exemptions from requirements of prescription and/or sale licence, subject to appropriate conditions.”

Arun Mishra, Head OTC Task Force, FICCI said, “The current crisis of pandemic has brought self-care and preventive care to the centre of our life and OTC medicines are an important tool when it comes to self-care. I believe bringing robust and internationally aligned OTC regulations will help the citizens of our country to be more informed about medicines and their usages in day-to-day common illnesses like cough and cold. Therefore, we urge the government authorities to expedite the review process and bring the regulation in the country.”

Amit Duggal, In-charge, Drug Control Wing- Chandigarh and Member of Subcommittee on OTC Regulations informed, “We have submitted the draft report of OTC Drug regulations along with the proposed OTC drug list to the Drugs Consultative Committee (DCC). We are hoping that the respective authorities take the necessary action for the implementation of the same.”

He informed, “Besides this, we have also given the definition of OTC drugs in the submitted report of OTC Drug regulations. It mentioned that ‘Drug’ is already defined in the Drugs and Cosmetics Act, 1940 under section 3(b) therefore, OTC Drug can be addressed as ‘sale to consumer/patient without the need of medical practitioner’s prescription of medicine.’

Giving an update on the submitted report of the subcommittee, Ahooja informed that during the 57th and 58th DCC meetings, the experts discussed this matter and the proposal is being forwarded to the DTAB with the recommendations of the OTC Subcommittee (Ahooja Committee).

Globally, there are many countries who have identified OTC drugs as a separate category of drugs and have defined their regulations as well. In India, there is no defined regulation for OTC drugs so far, but with the proposed OTC drug regulations it can be sold to customers without a prescription of a registered medical practitioner through a licensed chemist shop.