India has also had its fair share of tragedies due to “poisonous”, sub-standard or spurious formulations. Hence, quality control needs to be stringent, with criminal and financial liability on the perpetrators, industry experts told TOI.
“The Centre and state government need to come down heavily and swiftly on Maiden Pharmaceuticals. India — the pharmacy of the world with one-third of the global share in drugs (by volume) — cannot afford such tragedies,” a top official with a company said.
Consider these recent examples:
September 2022: Five patients died due to an anaesthetic injection, Propofol, at the Post Graduate Institute of Medical Education and Research, Chandigarh.
February 2020: 11 children died in Jammu and Kashmir due to Coldbest PC Cough Syrup, manufactured by Himachal Pradesh-based company Digital Vision.
October 2018: Batches of a polio vaccine manufactured by a Ghaziabad-based company were found contaminated with polio strain.
“These are a major issues of standards and controls. Even though regulations exist on paper, implementation on the ground is so very chequered. Hole-in-the-wall companies procure licences to manufacture drugs but follow little quality control,” said Ranjit Shahani, former VC & MD, Novartis India.
With 3,000 companies and over 10,500 manufacturing units across the country, the drug regulator faces a massive challenge in effective policing due to a shortage in personnel and funding. Further, India does not have a robust system of reporting adverse events. So safety checks in labs (by companies) and surprise as well as random checks (by regulatory officials) become imperative.
Reacting to the Gambia deaths, public health activist Dinesh S Thakur and lawyer Prashant Reddy T told TOI, “Schedule M in the Drugs & Cosmetics Rules, 1945 mandates testing of excipients. Indian pharmaceutical companies do not always conduct such testing. The need of the hour is a transparent and effective public health response. How many other batches used the adulterated excipient? Did the same trader sell the excipient to other manufacturers who used it to manufacture drugs without testing? Once the government has this information, it needs to take steps to withdraw all these drugs. Unfortunately, this is where the law is lacking — India has been trying to put in place a recall law since 1976 to no avail.”
Preliminary reports suggest the Haryana firm may have used sub-standard and cheaper excipients. Lab analysis of samples confirmed that they contain unacceptable amounts of diethylene or ethylene glycol (DEG) as contaminants, which is toxic when consumed and can prove fatal, according to WHO.