Multiple deaths and illnesses have been reported in several children after consuming a cough syrup manufactured by a private company in Rajasthan. As the cases send the Rajasthan government into action mode, shocking revelations have been made in an exclusive report by Dainik Bhaskar, saying that the suspended Drug Controller Rajaram Sharma has ‘changed’ the very definition of a fake drug in official documents, in an attempt to benefit some pharma companies in the state.
The Rajasthan government has suspended Rajaram Sharma and halted the distribution of all 19 drugs supplied by Kayson Pharma, as per reports. The Health Department stated that interference by Rajaram Sharma resulted in lowering the medicine quality standards based on their contents.
The Bhaskar report revealed, citing official documents, that the data of fake drugs sent by the Drugs department to the Lok Sabha earlier this year, as per a DGCA order, and to the NITI Aayog, carried misleading information and mismatched numbers. In another report sought by the Rajasthan Vidhan Sabha, again, mismatched numbers and misleading details were mentioned.
The Food Safety and Drug Control Commissionerate in Rajasthan had held a meeting between the Drug Controllers first and second, the Deputy Director of the Drug Testing Laboratory, and a junior legal officer of the department on September 19. Bhaskar has reported that the meeting found that Drug Controller (Second) Rajaram Sharma had added his own definitions of a fake drug, contrary to the established quality requirements in the Drugs and Cosmetics Act, 1940. Bhaskar has reported that they have minute-by-minute details of the said meeting.
Sharma had added definitions that meant that if the drug is missing one active ingredient and contains the others, it won’t be considered a fake or spurious drug. Whereas the Drugs and Cosmetics Act, 1940 requires all specified active ingredients to be present in a drug for it to be qualified as an approved product.
Basically, the changed definition added by Sharma brought down the quality standards needed and paved the way for substandard drugs to be passed as approved pharmaceutical products. The Bhaskar report says that Rajaram Sharma’s manipulation was aimed at benefiting at least 14 to 15 pharma companies supplying drugs in the state.
The Rajasthan Medical Services Corporation Limited (RMSCL) has stated that 10,119 samples of Kayson Pharma’s medicines have been tested since 2012, and 42 have been found to be substandard.
