Part of this inaction can be explained by government guidelines that discourage regulators from prosecuting a company for a substandard drug unless they can establish criminal intent or gross negligence, or the quality failure is deemed serious enough. Sunny Kaushal, an assistant drugs controller in Himachal, said that these guidelines meant the local regulator didn’t prosecute every case.
When substandard drugs made in a Himachal plant are sold elsewhere, or when the failure of a drug sold in the state was deemed minor, he explained, the regulator is only able to take “administrative action”. Such actions include suspension of the plant’s licence to make the drug in question, sometimes for as little as a few weeks. Kamat, the quality control expert, said such small penalties barely impacted revenues or deterred manufacturers.
But there are other barriers to regulators prosecuting successfully. Shri Singh, a criminal lawyer who has fought cases under India’s drugs laws, said drug inspectors do not have training or resources to build the kind of strong criminal cases required to convict manufacturers under Indian law.
In one 2014 case, the regulator failed to provide evidence that the drug in question had been stored at the right temperature. In another case, the judge ruled that the inspector failed to give Zee Labs its legal right to retest its substandard drug, and in another, the inspector failed to file a case to the supreme court within the legally given deadline. All three cases ended with the company being acquitted.