Last Updated on April 21, 2023 by The Health Master
The Gujarat high court issued notices to union ministry of health and family welfare, Drugs Controller General of India (DCGI), Food and Drugs Control Administration (FDCA) Gujarat, state government and two Gujarat based pharmaceutical companies in connection to a PIL (public interest litigation) for strict action against companies selling banned medicines in the Indian market.
“The court has sent notices to the Centre, FDCA and pharma companies Cadila Pharmaceuticals and JB Chemicals. The next for the hearing has been fixed for June 15. The PIL is keeping in view public health and to ensure that medicines that are banned all over the world are not sold in India,” said advocate Jay Thaker who is representing the petitioner Rajeshkumar Mishra.
In his application, the petitioner said his concern is about medicine reaching the human body and not giving its intended effect.
“Humans consume antibiotics as life-saving drugs. When LMX forte was not of approved standard quality, Cadila pharma was duty bound to report such serious quality issues to drug controller and immediately recall the whole batch which was not done,” it said, a copy of which HT has seen.
Mishra has claimed that he held two vials of medicine from the same batch “which were turning black”.
The petitioner claimed that massive dumping of substandard and banned drugs is being done in India.
Mishra is a visiting professor at LJ School of Law and a practicing advocate before Gujarat high court.
If Brand Aciloc is considered as an example, Cadila has sold Aciloc for nearly ₹190 crore in 2021 and ₹220 crore in 2022, it said. This value is nearly 50% of Indian market share of Molecule Ranitidine which is contaminated/adulterated, the PIL has alleged.
“Aciloc brand has been showing quality issues. Similarly, Drug LMX forte (Amoxicillin and Clavulanic Acid) was sold for nearly ₹1 crore each month in 2021 and 2022,” the PIL stated.
The facts pleaded in the petition are based on the information that Mishra has sourced from the market as well as from various photographs, videos as well as medicines. Some information is available on the public and individual source/s as well, the PIL said.
“Every big brand has brand managers. Brand managers from JB chemicals managing Rantac and Cadila Pharma managing Aciloc, which are top two Proton pump inhibitors PPI/anti-acidity sellers in the country must be joined for initial level probe by regulators. At this threshold level, the brand managers of Aciloc and Rantac must be interviewed in a protected environment and their answers must be placed on record of this Honorable Court,” the PIL stated.
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