Quality and safety issues “continue to haunt even the top companies” of the Indian pharmaceutical industry and there have been numerous instances of “data falsification”, “inadequate documentation” and “lax adherence to standard operating procedures” at Indian drug manufacturing sites, according to a study released by Commerce Minister Suresh Prabhu on Monday.
The study — titled ‘Enhancing Indian exports of pharmaceutical products to China’ — noted that there have been issues with the “efficacy of made in India drugs”. The study mentioned the case of Avandamet, an India-made drug which was found to contain less than required amounts of the main ingredient Rosiglitazone, rendering it ineffective. Avandamet is used to treat type II Diabetes.
“…increasing scrutiny from both domestic and external regulatory agencies (are) becoming the norm. Of the 42 warning letters issued by the United States Food and Drug Administration (USFDA) in 2016, nine went to Indian drug manufacturing sites. In December, for example, the FDA issued a warning letter to Wockhardt for data integrity violations,” the study noted.
Indian chemical industry is facing environment issues too. “The major industrial estates in Gujarat have been declared critically polluted and are facing issues on account of stringent pollution controls imposed by Central Pollution Control Board (CPCB) or State Pollution Control Board (SPCB)… Due to environmental moratorium, units in these industrial estates are not even allowed to change product mix within the stipulated environmental emission norms or undertake capacity expansion. For example, even the colour of dyes cannot be changed,” the study noted.
The study added that there has been a virtual ban on manufacturing new active pharmaceutical ingredients (APIs) in Gujarat as the pollution control authorities have not given them clearance “even within the permitted limits of treated effluent discharge”.
India imports around 80 per cent of active pharmaceutical ingredients (APIs) — raw materials required to make finished drugs — from China on volume basis. This is despite the cost of manufacturing APIs being similar in India as well as China, the study stated. China holds a dominant position in the global API industry given its large scale manufacturing capabilities, cost efficiency and adequate availability of commodity bulk drugs and intermediates due to strong technological capability and fermentation.
“There have been numerous instances of data falsification, inadequate documentation and data traceability, and lax adherence to standard operating procedures. Some have led to delays in drug approvals or to rejections of applications. Regulators have found pest infestations and dilapidated basic infrastructure at major manufacturing sites,” the study noted.