The Organisation of Pharmaceutical Producers of India (OPPI) is planning to submit elaborate data and safety profile of about a dozen to twenty drugs to the Drug Controller General of India by the end of this month, as part of its campaign to allow increased sales of prescription drugs over the counter.

The OTC committee of the association is currently working on the drugs that could be made OTC and is in the process of collecting data on safety and efficacy profiles of identified drugs, as directed by the Drug Controller General of India (DCGI) and senior health officials in response to its representation in this regard. The association would submit data forwarded by some of its active members to the government by the end of this month, Homi Bhabha, director, OPPI, told Pharmabiz.

“Many molecules in the category of cough and cold drugs, antacids, laxatives, topical creams against fungal and bacterial infections etc. are proven for its safety and efficacy for many decades. Many of these could be made OTC to boost its sales. We are looking at a dozen to twenty drugs in these segments. One of our members gave almost a truckload of safety and efficacy data on some of the drugs,” said Homi Bhabha.

Noting that about 570 molecules are under the prescription basket in India, he said as per the statistics only 0.6 per cent of doctors are available for every 1000 people in the country. Doctors, especially those working in rural areas, are struggling to devote more time for their patients. If at least a few molecules in the cough and cold and pain management segment made OTC, it could make big difference in reducing the workload of doctors. The current OTC basket in the country is only about 10 per cent of the domestic drug sales. Pain management, cough and cold segment is valued about Rs 400 crore. A liberal OTC environment would catapult sales of drugs in these segments. Further, the move would be beneficial to the rural population, as currently many traders and spurious drug makers fleece them exploiting their illiteracy and lack of knowledge.

David McLean, chairman, Asia-Pacific of Sudler & Hennessey said India is at least twenty years behind in the initiative to convert safe Rx drugs to OTC. “It started in USA, UK and Australia in the early 70’s. The biggest OTC switchovers include cough and cold drugs, anti-histamines, weight loss etc. and many brands proved to post huge sales. Benadryl was the first to leverage the ethical heritage in the switchover, happened during the 1979,” he noted. However, he declined to comment on the ethical issues involved in allowing prescription drugs as over the counter products in a developing country like India.