The cancellation of licences of 18 drug companies for the manufacture of spurious drugs, has sent out a strong signal on the adherence to good manufacturing practices (GMP), say drug-makers, on recent action taken by the Health Ministry.
Even though details are sketchy around the Health Ministry’s action on these companies, it comes at a time when certain cough syrups from India have come under the scanner in Gambia and Uzbekistan. This was followed by another incident linked to an eye-drop in the US, Recently, the Lok Sabha was informed of a medical alert from the World Health Organization on contamination in a product from India that was used to treat cancer and autoimmune diseases. This was reported from Lebanon and Yemen.
“Any violation of good manufacturing practices (GMP) is a public health hazard,” says Vivek Sehgal, Director General with the Organisation of Pharmaceutical Producers of India (OPPI), a platform of multinational drugmakers. They have been calling for the implementation of good manufacturing, distribution and promotional practices, Sehgal told businessline.
Pointing to the spurious drugs issue, he said, “to counter the issue of counterfeit drugs, while making basic information about the drug available to patients, the Drugs Technical Advisory Board (DTAB) has recommended introducing QR codes in drug products to help authenticate and track and trace these drugs across the supply chain. Such technology-aided solutions and forward-looking steps will help address the drug quality challenge.”
The adoption of blockchain-based pharma solutions can help ensure higher quality control across the value chain – vendors, distributors, bottling and packaging, and retailing, he said.
It is not clear if companies will be given time to remedy their manufacturing problems and get back to the regulator or whether they will remain shut - which raises concerns over its employees. Public health workers called for more details on the action, including the revoking of license on three products - whose details also have not been revealed by the Health authorities.
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