The United States Food and Drug Administration (FDA) has issued warning letters to five Indian pharmaceutical manufacturers so far this year for misbranding, selling unapproved medicines or violating current good manufacturing practice (CGMP) regulations, according to information available on the official website of the agency. Among these, four manufacturers were warned for selling unapproved and misbranded products claiming to mitigate, prevent, treat or cure Covid-19.
The first warning was issued by the FDA’s Center for Drug Evaluation and Research in March to Uttarakhand-based Windlas Healthcare. The letter summarised “significant violations of CGMP regulations for finished pharmaceuticals” at the company’s facility in Dehradun, based on an inspection by the FDA.
The inspection found that the firm did not maintain complete and accurate data from all laboratory testing. For instance, investigators found that while residual solvent testing of the active pharmaceutical ingredient (API) used to make multiple batches of tablets released to the US market, there were some “unknown impurity peaks” which were not reported as per procedure.
Proper testing of solvents is crucial in drug manufacturing – a toxic impurity in a solvent used in two different cough syrup batches made in Himachal Pradesh last year has allegedly resulted in the death of several children in Jammu and renal failure in a two-year-old girl in Baddi.
The FDA inspection found several other discrepancies in the laboratory testing and other practices at Windlas Healthcare, such as failure to establish an adequate quality control unit. In one of its responses to the agency, the firm attributed the root cause of testing violations to “inadequate knowledge and awareness” among the lab staff, the letter said.
The warning further said, “When our investigators arrived at your firm just 30 minutes after announcing our inspection, they observed numerous employees in the process of moving off-site carloads of trash bags containing shredded and torn documents and binders…our investigator noted that your live-feed cameras showed production staff expediently signing and passing documents to one another. Our investigator requested to visit the production staff location, however, he was routed to an incorrect area.” The firm acknowledged violation of documentation procedure by employees in its response, the letter added.
The FDA told the firm that its products would continue to be refused into the US if all the violations were not corrected. Corrective actions, if any, and further responses by the firm were not mentioned on the website.
The remaining four warnings were issued to companies selling Covid-related drugs in the US. Homeomart Indibuy at Belgaum was accused of promoting and selling Arsenic album 30 as the “best homeopathy preventive medicine for coronavirus infection”. Dr Dhole’s Sushanti Homeopathy Clinic was accused of selling an unapproved and misbranded new drug which claimed to be effective against pandemics.
Similarly, some vitamin C and other tablets made by Ahmedabad-based Kegan Wellness were being promoted as effective against Covid-19, and were termed misbranded and unapproved. Indore-based GBS dba Alpha Arogya India was accused of selling several ayurvedic products with claims on its website such as — “Can coronavirus be prevented? Here is the AYURVEDIC solution!”
The sale of all these drugs was banned until they were approved or branded correctly. Except Alpha Arogya, the three other firms took corrective actions, according to the FDA. The agency maintains a list of all fraudulent Covid-19 products, including a total of 101 warning letters issued to manufacturers so far.
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