Sections of Indian health groups and drug industry have expressed concern over what they view as a push by the department of pharmaceuticals (DoP) for an information dissemination mechanism that they say could subvert efforts by Indian manufacturers to release generic drugs.
The All India Drug Action Network, a consortium of phsicians and patients’ rights advocates, on Wednesday urged the government to probe “recent actions” by the DoP that AIDAN said could undermine access to affordable medicines in India.
The concerns relate to a proposal by the Organisation of Pharmaceutical Producers of India (OPPI), a body representing foreign drug-makers, to the apex drug regulatory authority to make public through an information portal all pending applications for drugs.
AIDAN, whose concerns are shared by sections of the Indian Drug Manufacturers Association (IDMA), a body of domestic drug-makers, said making available pending applications would arm foreign companies with information to launch “pre-emptive patent litigation to block generics”.
In a letter to Prime Minister Narendra Modi, AIDAN described the OPPI proposal as a “brazen move to outsource the job of finding potential patent infringers of its patents” to the apex drug regulatory authority, or the Central Drug Standards Control Organisation (CDSCO).
The letter, citing the minutes of a March 25 meeting called by the CDSCO, has pointed out that the DoP secretary, the department’s top official, appeared to advocate in support of the OPPI proposal. The minutes document that the secretary had suggested preparing a database for pending applications for new drug approvals or new manufacturing licences and publishing them on the CDSCO website.
The DoP secretary was not immediately available for comment on Wednesday.
OPPI’s director-general T.K. Kanchana said the industry body “believes a transparent regulatory structure is critical not only for better regulatory oversight but also for enabling patients to ensure that the drugs procured by them are from licenced manufacturers”.
She said that although India has over 15,000 drug manufacturers, the CDSCO’s own data show that only about 1,500 manufacturers are in compliance with rules that require companies to upload information about licences granted for the sale and manufacture of drugs.
AIDAN has pointed out that the OPPI demand has also been advanced by the Pharmaceutical Research and Manufacturers of America, a trade group representing the US pharmaceutical industry. It had pointed out that the CDSCO’s portal does not facilitate timely notification to a patentee of a possible infringement.
“Pending applications for new drugs should be treated as proprietary commercial information — there is no reason such information should be public,” said an official with the IDMA whose representatives had also participated in the meeting and were surprised by what they view as the DoP’s advocacy of the OPPI’s proposal.
“Our members expressed our concerns during the meeting itself,” the official said.
Members of AIDAN say companies could block new generic drugs for years through litigations claiming patent infringement even before they have been approved. “If companies think approved drugs infringe on their patents, they can approach courts after approval,” said Malini Aisola, AIDAN coordinator.