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Ramesh Shankar
Wednesday, December 28, 2022, 08:00 Hrs  [IST]

The Department of Drug Administration, Nepal has recently published a list of 16 manufacturing facilities of Indian pharmaceutical companies for failing to comply with the World Health Organisation’s Good Manufacturing Practices (WHO-GMP). The list of facilities which were not complied with the WHO-GMP standards included several big names in the industry such as the ayurvedic medicine facility of Divya Pharmacy, run by Yoga Guru Baba Ramdev’s DivyaYog Mandir (Trust), the facility of Cadila Healthcare at Sanand in Gujarat, IPCA Laboratories’ facility in South Sikkim, Zee Laboratories’ facility in Himachal Pradesh, Alliance Biotech’s facility in Himachal Pradesh, and Concept Pharmaceuticals’ facility in Maharashtra. Other companies listed by the Department for failing the WHO-GMP compliance included Radiant Parenterals, Mercury Laboratories, Dial Pharmaceuticals, and Marcus Laboratories in Gujarat; Captab Biotec, and Zee Laboratories in Himachal Pradesh; Unijules Life Sciences Ltd in Maharashtra; Anglowmed Ltd in Uttarakhand; Daffodils Pharmaceuticals Ltd in Uttar Pradesh; GLS Pharma Ltd in Telangana; and Shree Anand Life Sciences Ltd in Karnataka. The Department in a notice issued on December 18, has also come out with a list of 45 WHO-GMP compliant Indian facilities including that of Sun Pharma Laboratories, Dr Reddy’s Laboratories, Fresenius Kabi Oncology Ltd, IPCA Laboratories, Venus Remedies, Alkem Health Science, Alembic Pharmaceuticals, Shilpa Medicare, among others. While some of these facilities were already registered with the Department of Drug Administration, Nepal, some of the facilities are new. All these facilities were audited by the Department between March and July this year.

Of course, the latest salvo by the Department will prove to be rubbing of salt into the wound as the Indian pharmaceutical industry’s image has already taken a beating because of the Gambia tragedy. Earlier this year, the World Health Organisation had issued alert against four contaminated medicines - Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip N cold syrup - manufactured by the Haryana-based Maiden Pharmaceuticals that resulted in the death of 66 children in Gambia. Now the publication of the list by the Department will mean that the products from these facilities will not be able to export to Nepal. The Department in a notice has already asked the local agents in Nepal, which have been supplying these medicines, to immediately recall them. According to the notice issued by the Department, the medicines manufactured by the listed companies cannot be imported or distributed in Nepal. No doubt, these two back to back unpleasant incidents have spoilt the image of the country which has over the years donned the epithet of ‘the pharmacy of the world’ as Indian pharmaceutical companies have been exporting affordable and quality medicines to over 200 countries across the world including developed nations like the US, UK, Japan, EU, etc. As the country’s pharmaceutical industry’s image has taken a severe beating, there is pressing need to increase monitoring of WHO-GMP drug manufacturing units by the State Licensing Authorities (SLAs) in the country. It is the SLAs who issue Certificate of Pharmaceutical Product (CoPP) to the drug manufacturing units under the WHO-GMP Certification Scheme for the purpose of international commerce, i.e., for registration of products in foreign countries. India is 3rd largest country in pharmaceutical manufacturing in volume with the highest number of US FDA approved plants outside the US. This has been possible not only due to economical pricing but by adhering to the global standards also. The Indian pharmaceutical industry has been able to build this positive reputation over the last three decades with the support of the government. So, it sounds very strange that the pharmaceutical units presumably holding WHO-GMP are found deficient by overseas regulators. It is time for the drug regulatory authorities in the country to look back and take stock of the present situation.


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