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OTC DRUG POLICY

Ramesh Shankar
Wednesday, May 25, 2022, 08:00 Hrs  [IST]

The Organisation of Pharmaceutical Producers of India (OPPI) has recently conducted a survey ‘Value of OTC drugs in India’ which has revealed that Indians spend around Rs. 36,000 crore annually on treatment of 27 minor ailments including acidity, indigestion, constipation, diarrhea, cold, cough, allergy, headache, joint pain, back ache, body ache, fever, menstrual pain, dental pain, acne, intimate hygiene, cuts/burns/wounds, weakness, tiredness, anemia, eye strain, sleeplessness, smoking control, etc. The study, conducted by OPPI along with Havas Life Sorento, a healthcare communication firm, further revealed that healthcare professional spends contributed 86 per cent to the total spends while self-medication accounted for just 10 per cent. The fact is that all these minor ailments can, up to an extent, be treated without consulting a doctor if the country had a robust over-the-counter (OTC) drug policy. In a country like India, where the cost of primary healthcare is expensive, a robust OTC policy will considerably bring down the cost of primary treatment by providing patients safe, effective and easy access to OTC products. The OTC policy will surely drive health literacy and responsible self-care among consumers through authentic information, tools and guidance which will substantially bring down out-of-the-pocket healthcare spend in the country. The survey further revealed that there is enormous potential for consumer behaviour to change positively and help increase the savings on healthcare spend by diverting treatment of minor ailments to self-medication. Now, the captains of pharmaceutical industry have urged the government to implement a robust OTC policy with clear guidelines for promotion and sale of OTC drugs which will be a win-win situation for both the industry as well as the patients. While it will help the pharma industry grow, for the patients their dependence on medical practitioners for minor ailments will drastically come down, thus saving a substantial amount of money and time.

Unlike US, European Union and Australia which have well defined OTC law, at present India does not have an OTC policy. The drug regulators in the country are in fact seized of the issue as an OTC drug policy has been in the works for more than five years. During the 52nd meeting on September 18, 2017, the Drugs Consultative Committee (DCC) of the Union Health Ministry had recommended for the creation of a separate category of OTC drugs. A subcommittee was set up under the chairmanship of Dr. Ravi Shankar, Drugs Controller, Andhra Pradesh, 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 advertisements and pricing, etc. In the 55th meeting on February 1, 2019, the DCC set up a subcommittee under the 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. The Ahooja Committee recommended promotion of self-care without compromising patient safety thereby reducing treatment costs and suggested 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. Based on the recommendations of the Ahooja Committee, the DCC recommended that suitable amendment should be introduced in Schedule K 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 issue is still gathering dust in the shelves of the Union Health Ministry. In a country like India where the doctor-patient ratio is skewed, a well defined OTC policy is crucial.

 

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