Drug makers want free hand in pricing and advertising OTC drugs

Currently there are no specific regulations governing the sale of OTC products and this impacts both patient safety and access, says OPPI

Drug makers want the government to exempt over-the-counter (OTC) products from price control and lift the restrictions on advertising.

These are among recommendations made by a task force consisting of domestic and foreign drug makers. Currently there are no specific regulations governing the sale of OTC products and this impacts both patient safety and access, Organisation of Pharmaceutical Producers of India (OPPI) said on Friday. The recommendations are in response to a government proposal for a policy to regulate OTC sales.

Many drugs, such as those for common ailments like fever and pain, are sold as OTC abroad but require a prescription in India. Ayurvedic products do not require a drug sale licence and can be sold through provision stores without price control.

In 2016, India’s OTC market grew eight per cent to $2.7 billion with a five-year CAGR of nine per cent, according to Nicholas Hall’s global OTC sales database.

OPPI, which represents foreign drug makers, has proposed norms regarding drug classification, labeling, distribution and pricing. It has suggested the inclusion of prescription drugs for cold, cough, pain, allergies, skin infection among others, in the OTC category and also suggested new licensing norms for its sale.

“Based on increased availability of OTC products, competitive forces will lead to economic pricing. Hence, OTC products should be considered for price control exemption,” OPPI said. Aspirin and vitamins which are sold as OTC in India come under price caps.

OPPI has said advertising of all OTC products should be allowed in all media but should not be deceptive and the advertisement should not guarantee effects or cure.

“Access to medicines in India has long ignored the critical role of the viability of OTC medicines in the remotest areas. A well-regulated OTC guideline will expand access for patients,” OPPI president A Vaidheesh said in a statement. “A well-regulated OTC guideline promotes a favourable ecosystem that educates patients on responsible self-medication, empowering them to manage their health by themselves,” Kanchana TK, Director General, OPPI added