New Delhi has asked diplomatic personnel stationed in key European countries to try and avert any adverse fallout on India’s generic drug exports from the recent moves by Europe’s medicine regulators against the clinical studies for generic drug validation conducted by Hyderabad-based GVK Biosciences.
The regulators, including the European Medicines Agency (EMA), France’s ANSM as well as their German, Belgian and Luxembourgian counterparts had suspended many ‘authorised’ medicines, whose “marketing authorisation applications included clinical data from studies conducted by GVK Biosciences at its Hyderabad site”. ANSM had initially “raised concerns on the reliability of the clinical part of bio-equivalence studies conducted between 2008 and 2014” by GVK Biosciences.
While the issue is restricted to the alleged flaws in GVK Biosciences’ studies, government sources in New Delhi apprehend that it could potentially lead to a clampdown on India’s pharmaceutical exports to the continent.
Pharmaceutical exports from India are currently worth around $15 billion per annum. Domestic sales are roughly of the same order too, with (branded) generics making over 90% of the market, where patented medicines are gradually increasing their share.
The aim of the “diplomatic campaign”, according to official sources, is to make the regulators reconsider their findings, reverse them and restore the reputation of GVK Biosciences and the Indian validation procedures.
Official sources told FE that the Modi government has asked the heads of India’s diplomatic missions in EU member countries and at the European Commission (EC)-level to take up the issue with the concerned authorities and ensure that it is not “blown out of proportion” by “vested interests” supporting the Big Pharma (innovator drug companies).
The EMA’s findings, the sources said, have been forwarded to the EC to take a final decision that will be legally binding on all EU-member countries. They added that India registered its “protest” against the recommendations of the EMA and ANSM to suspend the medicines exported based on GVK’s studies.
Sources from the domestic drug industry, however, ruled out the possibility of the European regulators taking action on Indian medicine exports as a whole based on their (regulators’) concerns over GVK Biosciences and turning the episode into a big crisis. They said this was a routine regulatory issue and could be addressed by the firm by convincing the regulators through the normal procedures. The government’s move to take up the matter diplomatically could prove to be counter-productive, these sources, who did not want to be quoted, said.
The clinical studies by the Hyderabad-based company were for authorising the efficacy/safety/bio-equivalence of these generic medicines used to treat ailments including blood pressure, ulcers, allergy, dementia, cardiac problems, restlessness and depression.
Though GVK Biosciences did not respond to an email sent to it by FE, a company spokesperson claimed that its clinical studies for the same drugs have been approved by the US Food and Drug Administration. The spokesperson added that separate tests conducted in independent laboratories at the request of the marketing authorisation holders of the same drugs suspended by the EMA also confirmed that GVK Biosciences had followed good clinical practice (or GCP — international standards regarding the manner in which clinical studies are conducted).