Tougher regulatory watch soon be endorsed on Domestic API producers


Active Pharmaceutical Ingredient (API) producers in India, soon going to face tougher stringent quality checks and frequent site inspections in the coming days as poor bio-available products of dubious origin are found to be entering the drug supply chain. To make bulk drug producers more restrictive to follow quality and safety concerns, The state drug controllers have been seeking provisions to have endorsed tougher regulatory watch at its recent meeting with the Drug Consultative Committee (DCC).

Drug controller from Punjab state raised his concerns on the issue of poor-quality bulk drugs at the DCC meeting.  Drug officials found Active Pharmaceutical Ingredient (API) supplied by various manufacturers are not as per defined specifications with respect to their quality, specifications, and purity and in some cases, the drugs are poorly bio-active or bio-available.

Drug officials also shared that the reason behind poor bio-active or bio-available API’s maybe because of their manufactured defects like it may not be produced at the right premises or are not manufactured with the required scientific techniques to produce the bio-active substance.

After all discussions, 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.

Commerce Minister Suresh Prabhu published a study with a title ‘Enhancing Indian exports of pharmaceutical products to China”  last year, stated that there have been issues with the “efficacy of made-in-India drugs” and 80 percent of API imports from China. The study also highlighted 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.

It’s been a long time since the domestic pharmaceutical sector has been grappling with quality issues.

The government steps forward to take strict regulatory actions 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. 40 percent of the rise in the price of some APIs noted in the last few months in the Indian market. Due to high prices, drug producers struggled to fulfill their contractual obligations. According to industry representatives, with the ramped up production of Indian companies, the situation is mostly under control.

Sathish W. Wagh, Chemical Export Promotion Council (Chemexcil) Chairman shared with Media that as the regulators remain concerned over the quality of bulk drugs, the industry remains disappointed with the existing regulatory climate. Drug producers still face several environment hurdles on so many clearances. He also added that our country needs to revamp our outdated rules to be competitive in the global market.

The present rules don’t permit a domestic producer to go for capacity expansion or diversification to accomplish market demand without prior consent from pollution control boards even if there is no change in pollution load. Six months of time an approval can take to arrive.

To compete with Chinese firms in pricing, there is a requirement of a functional central effluent treatment plant, connected units should be allowed to send effluent after neutralizing it. With this way, treatment cost, which is more than 10 percent of the total cost, will come down substantially.


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