Attempt to Sue Indian Drug Regulators in Indian Supreme Court Fails but Provides New fodder to Critiques 
[Posted on: Thursday, 17 March, 2016]

Since the 2013 DOJ ruling against the Indian generic manufacturer, Ranbaxy, Indian manufacturers have been constantly in the news for all the wrong reasons. Although India is home to one of the World’s largest generic drug and API manufacturing industry with about 700 FDA-approved manufacturing facilities, the general impression is that Indian regulations are lax, and the Indian regulators are either incapable of enforcing the law or are corrupt. Inspections by US FDA found data integrity issues and many serious violations of the GMP rules at multiple sites. A few sites have been banned and many others subjected to Warning Letters and other actions. Inspections by other non-Indian regulatory agencies have been less critical. Due to lack of pharmacovigilance data, it is anybody’s guess as to how many patients have been injured by consuming presumably poor quality drugs manufactured in India. But it is generally agreed that Indian drug manufacturers follow two standards, one for exported products and another for indigenous consumption with the latter being of much poorer quality than the former. A well-known activist, Dinesh Thakur, had filed public interest petitions with the Indian Supreme court suing the Indian regulatory agency, CDSCO, and Ministry of Health and Family Welfare and the other government officials claiming that these agencies should be reformed to address the deficiencies. In the petition, Mr. Thakur, presented several documents as evidence of lax rules, seemingly corrupt practices, and poor standards of regulations. The petition cites a few cases to highlight the points. Unfortunately, the only companies cited by name in the petition are non-Indian companies while Indian companies are not cited by name by implied by extrapolation. Mr. Thakur’s team presented a detailed analysis of the status of drug manufacturing practices based on publicly available documents or documents secured through Right to Information (RTI) requests to government offices. RTI is similar to the Freedom of Information (FOI) requests in the US. The Supreme Court of India refused to hear the petition based on two criteria: First, Mr. Thakur is not an Indian citizen so his motivation was suspected. Second, the petition does not identify any public party affected by the petition, such as a person who got injured by consuming sub-standard drugs sold in the Indian market. It is easy to criticize the courts but the courts adopted a standard for hearing no different than any other jurisdictions in the World. However, the petition is an interesting read on anyone interested to understand the inner workings of the Indian regulatory agencies both at the central and at the state levels. Mr. Thakur has been an outspoken critic of India drug industry ever since the Ranbaxy ruling was announced in 2013. He lives in the US and most likely does not anymore have direct interactions with any Indian drug company. His petition did not cite any Indian party. There has been very little criticism of Indian drug companies in India providing lack of public or political support for such petitions. It is unfortunate that due to this disconnect between non-Indian and Indian perceptions of acceptable practices in the drug industry, it is hard to reach a conclusion that is not anecdotal. It raises a lot of red flags but not many hard evidences. While Mr. Thakur finds a very receptive audience in the US, it seems he gets little support in India. Even this news was not a big news in Indian media. Indian drug regulators have been slow to change. And it will likely stay this way for the near future.