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TREAD CAUTIOUSLY ON OTC POLICY

Ramesh Shankar
Wednesday, May 1, 2024, 08:00 Hrs  [IST]

The All India Organisation of Chemists and Druggists, representing around 10 lakh pharma traders across the country, is vehemently opposing the Union Health Ministry’s proposed move to allow sale of over-the-counter (OTC) drugs at general and grocery stores. Of course, the ministry is now in the process of creating an exclusive Schedule of OTC drugs in the country. The Drugs Consultative Committee of the ministry had earlier approved the creation of a separate OTC drug category by including medicines for minor illnesses such as fever, cough and cold and certain common allergies. For wider consultation, the ministry had formed a sub-committee comprising of five state drug controllers which had also recommended a list of drugs which can be considered for marketing as OTC drugs along with conditions to be followed. But now, the AIOCD argues that the ministry’s proposal is a violation of the Drugs and Cosmetics Act, 1940; the Pharmacy Act, 1948; and the Pharmacy Practice Regulations of 2015. They emphasize that selling drugs without proper licensing and pharmacist supervision will contravene existing laws aimed at ensuring the safe dispensation of medications. The absence of pharmacist consultation services at general and grocery stores raises apprehensions about inadequate medication management and the potential for self-medication errors. The AIOCD further argues that the proposal raises concerns about self-medication practices, potentially leading to incorrect diagnoses, dosage errors, and adverse health outcomes. Underscoring the crucial role of pharmacists in providing therapeutic advice, ensuring proper dosage, and mitigating adverse drug reactions, the AIOCD argues that with nearly 9.80 lakh retail chemists and 13.50 lakh pharmacists across India, the existing supply chain and retail outlets are sufficient to meet the country's medication needs. Apparently, the AIOCD is concerned over legal violations, public health risks, and the potential for drug abuse.

There can be no two opinions about the fact that the intention of the government in creating an exclusive schedule of OTC drugs is good as it will improve accessibility and affordability of healthcare in the country, especially to the poor patients and those who reside in the remote areas. It is true that minor ailments can, up to an extent, be treated without consulting a doctor if the country has an 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. In India, a large percentage of people are still not in a position to bear the cost of treatment and the doctor's fee. Once schedule of OTC drugs comes out, patients will have no botheration of visiting doctors for treating common ailments.  But all said and done, the AIOCD’s concern should be taken with all its seriousness as at stake is nothing other than public health. The government should move with caution as a considerable section of patients in the country still requires to be educated on the use and side-effects of OTC drugs. Though the OTC drugs are generally those that are effective for minor ailments and extremely safe to use, there should be some mechanism in place to prevent the indiscriminate sale of these drugs. For this purpose, the point-of-sale should be clearly defined and the labeling norms will have to be adequately revised to make it easier for consumers to read and understand its contents. Then there is the issue of similar sounding brand names with different drugs, which should also be addressed by the government. If need be, the government should go for another round of comprehensive stakeholder consultation before finalising the OTC policy.

 
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