In what can be a major push to the Indian generic exports to the African markets and make them competitive, countries like Nigeria, Ethiopia and Kenya are actively considering the recognition of Indian Pharmacopoeia.
The delegations from the Drug Control General of India (DCGI) and the Indian Pharmacopoeia Commission (IPC) are expected to visit these countries for formal discussions and finalisation of the agreement in this regard, it is learnt.
The move comes after the strong representations and pursuance by the Pharmaceutical Export Promotion Council of India (Pharmexcil) which has been pushing the idea through the Ministry of Commerce for global recognition of IP at par with the United States Pharmacopoeia Convention and European Pharmacopoeia.
“We had made strong presentations before the African countries to begin with our efforts. We presented the cases of 10 select monographs from IP and compared in detail with those from USP and EP. It was established that the monographs in all these three pharmacopoeia were the same word by word, thus prompting the regulatory authorities to take the claim seriously,” Pharmexcil Africa panel chief Bhavin Mehta told Pharmabiz.
The Pharmexcil also has taken up the issue with the Latin American countries in the same manner. The representations and discussions were held with Venezuela, Chile, Peru and Columbia and the regulatory authorities had taken note of the claim, he added.
It is also learnt that Sri Lanka has virtually started accepting the IP for the generic drugs being imported from India, though no official announcement was made.
The Pharmexcil, especially the SME panel, has been pursuing the matter with the authorities for a long time now. Recently, a delegation led by vice-chairman and SME panel chief had met the Commerce Ministry to take up the matter with the respective countries so that the benefits could be passed on to the importers and making the quality drugs affordable.
The delegation also urged the Commerce Ministry to make recognition of IP a mandatory clause in all future bilateral agreements between India and other countries in the pharmaceutical sector. Accordingly, the issue was discussed with Brazil by Commerce Minister Anand Sharma during his recent visit.
It was pointed out by the Pharmexcil that if the IP was recognised internationally, the manufacturers can reduce the prices and make Indian drugs competitive in the global market. The recognition will reduce operating costs of testing and other mandatory procedures.