Domestic API Makers To Face Stringent Quality Checks As Poorly Bio-Available Products Enter Drug Supply Chain
New Delhi, 13 March 2019: The domestic active pharmaceutical ingredient (API) manufacturers will face stringent quality checks and more frequent site inspections in the coming days as sub-standard products of dubious origin are found to be entering the drug supply chain. The state drug controllers have been seeking provisions to make bulk drug manufacturers more accountable for quality and safety, and taking a serious note of the issue, the Drug Consultative Committee (DCC) is learnt to have endorsed tougher regulatory watch at its recent meeting.
At the DCC meeting, drug controller from Punjab raised the issue of poor-quality bulk drugs. The officials noted that in many cases, APIs supplied by various companies are “found not as per defined specifications with respect to their quality, specifications and purity” and in certain cases the drugs are poorly bio-active or bio-available. “It is suspected that either such APIs are not manufactured at the right premises or are not manufactured with the required scientific techniques to produce the bio-active substance,” they stated. After deliberations, the DCC has recommended that the state drug controllers should take action as per Drugs and Cosmetics Rules and test samples “as much as possible” to ensure the quality of APIs.
The domestic pharmaceutical sector has been grappling with quality problems for a long time. While India imports around 80 per cent of APIs from China on volume basis, a study released last year by Commerce Minister Suresh Prabhu, 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 for type II diabetes, which was found to contain less than required amounts of the main ingredient rosiglitazone, making it ineffective.
The government move to tighten regulatory oversight comes at a time when the domestic API industry is re-establishing its production capability in the wake of supply disruption over a Chinese anti-pollution push and steep price rise. The price of some APIs had gone up by 40 per cent in the last few months in the Indian market and many drug manufacturers struggled to fulfill their contractual obligations. However, with the ramped up production of Indian companies, the situation is mostly under control, say industry representatives.
As the regulators remain concerned over the quality of bulk drugs, the industry remains disappointed with the existing regulatory climate. “We still face several environment hurdles on so many clearances. We need to revamp our outdated rules to be competitive in the global market,” Chemical Export Promotion Council (Chemexcil) Chairman Sathish W. Wagh told Pharmabiz.
According to industry representatives, the existing rules don’t allow a domestic manufacturer to go for capacity expansion or diversification to meet market demand without prior consent from pollution control boards even if there is no change in pollution load. The approval can take up to six months to arrive.
The volume of effluent generated from API manufacturing is insignificant compared to large chemical plants. “Wherever there is a functional central effluent treatment plant, connected units should be allowed to send effluent after neutralising it. With this single measure, treatment cost, which is more than 10 per cent of the total cost, will come down substantially. It will help us compete with Chinese firms in pricing,” an industry expert added. Pharmabiz