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Pharma industry captains vouch for OTC policy

A robust over-the-counter (OTC) policy could help patients save Rs30,730 cr

Pharma industry captains vouch for OTC policy
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Pharma industry captains vouch for OTC policy

Indians spend Rs 35,820 crore annually on treatment of 27 minor ailments. Healthcare professional spends contributed 86% (Rs 30,730 cr) to the total spends of Rs 35,820 cr while self-medication accounted for just 10%, reveals a survey. If there is a clear OTC policy, the healthcare professional spend of Rs 30,730 crore can be saved by the patients

On March 24 this year, the Organisation of Pharmaceutical Producers of India (OPPI), which represents the research-based pharmaceutical companies in India, has come out with a survey report 'Value of OTC drugs in India' which in all practical purposes advocated for a robust policy with clear guidelines for promotion and sale of over-the-counter (OTC) drugs for substantially bringing down the out-of-the-pocket healthcare spend in the country. In a country like India, where the cost of primary, secondary and tertiary healthcare is expensive, the findings of the survey hold much water.

The survey has revealed that Indians spend Rs 35,820 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, stated that healthcare professional spends contributed 86 per cent (Rs 30,730 crore) to the total spends of Rs 35,820 crore while self-medication accounted for just 10 per cent. It is clear that if there is a clear OTC policy, the healthcare professional spend of Rs 30,730 crore can be saved by the patients.

OTC drugs are medicines that can be purchased without a medical prescription from a doctor or other health care professional. Of late, there has been a clarion call by the healthcare experts in the country for creating a robust regulatory framework for OTC medicines that will enable and facilitate the creation of a positive list of OTC medicines and ensure their widespread availability across the country, including in the remote areas. No doubt, OTC medicines are a critical component in advancing consumer health as it allows people to self-treat and manage their health conditions, especially minor ailments, conveniently and responsibly. A robust OTC policy will surely help bring down the cost of primary treatment by providing patients safe, effective and easy access to OTC products. The policy will empower Indians to self-medicate through clear and useful information about the right product for right ailment at the right time, thus enhancing health outcome and limit harm from misuse and abuse of drugs. The OTC regulation will increase engagement with pharmacists and evolve their role to be well informed influencers to advocate responsible self-medication practices. It will create a favorable switch policy for potential OTC drugs which are safe, effective and enjoy a high level of trust among healthcare professionals.

But sadly, unlike US, European Union and Australia which have well defined OTC laws, OTC drugs are not defined as a separate category of drugs in the Drugs and Cosmetics (D&C) Rules in India. It is not that the Indian government is not aware of the development. As the issue caught the attention of the Indian regulators, the Union Health Ministry in 2017 constituted a subcommittee under the chairmanship of Dr. Ravi Shankar, 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 in 2019 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.

However, in February 2019, the ministry set up another subcommittee under the chairmanship of NK Ahooja, Drugs Controller, Haryana to look into the report submitted by the Shankar Committee and submit its recommendations for further consideration. The Ahooja committee stressed on the need to define OTC drugs in the D&C Rules and laid down specific provisions for the regulation of OTC drugs. It recommended promotion of self-care without compromising patient safety thereby reducing treatment costs. Of course, the sub-committee has made some sweeping recommendations to the government on OTC drugs. It recommended to the government to classify the OTC drugs into two separate categories - one for those drugs that can be sold in retail outlets and the second category for those drugs that can be sold under the supervision of a registered pharmacist. The panel had come to the conclusion that there is an urgent need to define the OTC drugs and to lay down specific provisions for the regulation of OTC drugs in the country.

The pharmaceutical industry captains have long been urging the Indian government to introduce a robust OTC drug policy to reduce out-of-the-pocket healthcare spend. So, the government should not further waste time in forming committees after committees. It is time to act as the Indian healthcare ecosystem will immensely benefit from a robust OTC policy.

(The author is freelance journalist with varied experience in different fields)

Sreeja Ramesh
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