CDSCO seeks views on level playing field for new drugs

India's drug regulator has sought comments from pharma industry stakeholders on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials and have an easier path to obtaining approvals for a product launch.

Experts, however, believe that instead of making drugs cheaper, the move might end up making them more expensive.

According to the note circulated by India's regulatory agency - Central Drugs Standard Control Organization (CDSCO) - there is "lack of level playing field" between the first company that obtains a new drug for the first time in the country based on clinical trial and bioequivalence study data and the subsequent applicants that obtain approval of the same new drug based on bioequivalence study data. Costs of regulatory compliance are lower for the second grouping that can skip clinical trials.


KM Gopakumar, Co-Convenor, Working group on Access to Medicines and Treatment, said that as far as the originator companies are concerned, there is no need for further incentive to recoup the expenditure of drug development.

"Patents provide market exclusivity for 20 years, which provides enough opportunity to recoup R&D expenditure. If Indian generic companies are applying to introduce new drugs in the Indian market, they should not be asked to carry out local clinical trials except in cases where there is a scientific rationale requiring a bridging study," he said. "Generic approval should be given on the basis of bioequivalence studies. Thus, by applying a scientific approach, the level playing field question never arises," he said.

This move by the drug regulator is "worrisome," he said, adding that it appears to be a precursor to accommodating the demands of pharmaceutical transnational corporations from the US, EU, and Switzerland - namely, data exclusivity.

"The DCGI needs to focus more on improving the safety and efficacy of medicines rather than on creating a level playing field," he said.

Many also believe that this will make the drugs expensive.

"While the company conducting the clinical trial may get an edge, the generics will not benefit from this. The company conducting the trial gets enough exclusivity and there is no need for any further extension. This will only make drug prices go up," said a pharma expert, on the condition of anonymity.