With more countries tightening norms and requirements on bioequivalence (BE) studies for marketing the drugs in their countries and thus putting added pressure on the exporters, the union commerce ministry is planning to take up the issue with respective countries for relaxing the norms at least in the case of old drugs.
After the industry through representations took up the hardships in this regard with the authorities, the Commerce Ministry is planning to take up the issue at 'appropriate forums', apart from mulling on the proposal to extend financial support to the companies under Innovation Fund to cover the expenses of BE studies.
Sources said India will prepare a list of old drugs where there were no problems in bioavailability/bioequivalence (BA/BE) as reported by the World Health Organisation (WHO) and cleared by concerned regulatory authorities of foreign countries. The list will be shared with the respective countries for seeking exemption from further BE requirements for exports, it is learnt.
Industry pointed out that the tightened norms, now being followed by almost every country, had put pressure especially on the small companies as it requires huge amounts for tests and get their products registered for marketing. Besides, it was also leading to long delay in the registration as certain countries were implementing rigorous procedures in this regard.
The Commerce Ministry is learnt to have already instructed the Pharmaceutical Export Promotion Council of India (Pharmexcil) to discuss the issue with the experts in NIPER and the WHO to examine the matter and prepare the list of possible drugs for exemption.
Besides, another suggestion was also being considered to cover the BE expenses incurred by the companies under the Innovation Fund. The industry had also forwarded the suggestion to cover the expenses under the market assistance scheme available for the exporters, sources said.