In the last two years, generic medicine samples belonging to 14 per cent of a total of 468 companies that were test-checked by the state government, were found to be either fake or of inferior quality.
Of the samples taken from 468 companies and tested in Gujarat, samples of a total of 65 companies were found to be either fake or of inferior quality, as of August 2019. Of these erring companies, 34 belonged to Gujarat while the rest 31 were based outside the state, the Gujarat Assembly was informed in a written reply to an unstarred question asked by Congress MLA from Wankaner, Mohammed Javed Pirzada, during the fifth session of the legislature that concluded earlier this week.
Among the erring companies from Gujarat, 18 were based in Ahmedabad, while four each were from Mehsana and Gandhinagar and three from Vadodara. Some of these generic companies were based in Kheda, Banaskantha and Surat as well. In most of the cases, show cause notices were issued and permission to manufacture was either suspended or cancelled. The cases of 31 erring companies from outside the state were referred to the state’s drug controller, the state government stated in its reply.
The companies from outside the state found selling inferior quality or fake generic drugs in Gujarat were largely from states of Madhya Pradesh (7 companies), Uttar Pradesh (6), Himachal Pradesh (6) and Maharashtra (4). Companies from Andhra Pradesh, Delhi, Karnataka, West Bengal, Tamil Nadu and Haryana were part of the list tabled in the state legislature.
According to the Food & Drugs Control Administration (FDCA), Gujarat, both Ahmedabad and Vadodara are leaders in the production of generics, while Ankleshwar and Vapi produce most of India’s bulk drugs.
When asked about the failure of samples of generic medicines checked by the government, HG Koshiya, Commissioner, FDCA, Gujarat, told The Indian Express that the failure rates of generic medicine samples tested were within accepted limits.
Though the Commissioner did not put a figure to the failure rate, he said, “In a special drive held in July 2019, we had tested 25 life saving antibiotic molecules sourced from 20-odd Pradhan Mantri Bhartiya Janaushadhi Kendras, which are being sold at cheap rates, and all were found to be okay. It is very rare that a licensed manufacturer in Gujarat ends up producing spurious drugs. Most of those caught are fly-by-night operators.” There are 510 Pradhan Mantri Bhartiya Janaushadhi Kendras in Gujarat that provide commonly used generic medicines covering all therapeutic groups.
“Of the 13,616 samples of all drugs tested in Gujarat which also includes generic medicines, only 395 were found to be NSQ or not-of-standard-quality. Compared to a failure rate or NSQ of 8 percent that existed in 2011-’12, it is now at 2.9 perc ent in 2017-’18. The quality of product is improving due to the strong enforcement from the government’s side,” Koshiya said, also comparing the quality of drugs in Gujarat with those manufactured by companies based outside the state. “Among the tested samples, the percentage of NSQ samples or failure ratio of drugs manufactured by pharmaceutical firms in Gujarat was just 1.69 per cent, while the NSQ samples belonging to manufacturers from outside the state was as high as 4.62 per cent.”
Earlier this year in April, a report from the Office of the United States Trade Representative (USTR) stated that India was one of the “leading sources of counterfeit medicines distributed globally. “While it may not be possible to determine an exact figure, studies have suggested that up to 20 per cent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety,” the report stated. It also quotes the Organisation for Economic Cooperation and Development (OECD) and says that OECD found that 55 per cent of global seizures of counterfeit pharmaceuticals, by total value, originated in India — making it the largest producer by far. India had trashed the US report stating that it was an attack on cheap generic drugs.