Several large Indian pharma companies under US FDA scrutiny

Recent regulatory action by the FDA on leading Indian firms has affected the country's exports, according to Chairman of Dr. Reddy's Laboratories

Natco Pharma has received Form 483 notifications from the US FDA, after the US drug regulator inspected two of its manufacturing units in Chennai and Hyderabad. The FDA conducted inspections at the company's active pharmaceutical ingredients (API) manufacturing facility at Manali, near Chennai, and the pharmaceutical formulations facility at Kothur, near Hyderabad, in early February and March respectively.

The company has said that the observations would not have an adverse impact on its current or future products, and that it had already sent response and compliance reports for these observations.

Large drug companies like Wockhardt, Sun Pharma, Lupin and Ipca, which are currently facing problems because of FDA warning letters and notices, are trying to address the problem. The companies have come together to form a quality forum and are consulting global experts, including both MHRA/EDQM and US FDA, to tackle the issue.

Recently, the FDA warned generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant at Hinjwadi, Pune. The agency had already banned imports from the plant in July, except for some drugs, such as cancer medicine carmustine, antipsychotic haloperidol and antibiotic amikacin.

The FDA had also made nine 'observations' highlighting violations of its norms at Wockhardt's new facility at Shendra in Aurangabad.

From 2008-2015, the US FDA issued around 50 warning letters to Indian companies. Out of these, around 40% were converted into import alerts. Only a third of warning letters issued between 2008 and 2013 have been resolved; a majority of these involved large companies.

Sun Pharmaceutical, Dr. Reddy’s Laboratories, Cadila Healthcare and IPCA Laboratories were major companies that faced the USFDA heat in 2015. Dr. Reddy’s Laboratories' Chairman Satish Reddy has asserted that recent regulatory action by the FDA on leading Indian firms has affected exports from the country. Reddy said that a dialogue between the Indian government and the US regulator was essential in resolving the issue.

Though Indian exports of pharma products has grown by 9.7%, the trend used to be in double digits before the USFDA crackdown. 'Even though we are growing, we are not growing according to the potential,' pointed out Reddy, adding that there were several factors that have affected exports to the US market.

Dr. Reddy’s had received a warning letter from the USFDA in November last year relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana. In response to that letter, CEO G V Prasad had said the company was in the process of shifting some products from the affected plants to other facilities and considering third party assessment for its plants. The US federal agency had also asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data, while also including a detailed action plan to fully investigate the scale and root causes of 'deficient documentation and data management practices.'

In April Dr. Reddy's Laboratories' US arm said it is recalling 3,342 vials of anti-osteoporosis injection, made by Hyderabad-based Gland Pharma, on account of lack of assurance of sterility. The recall is being carried out by Dr Reddy's Laboratories Inc for 5mg/100mL (0.05mg/mL), 100 mL single use bottle of Zoledronic Acid. Gland Pharma is producing the injection at its Dundigal facility in India.

Meanwhile, as a consequence of the USFDA warning letter to three of Mumbai-based Ipca Laboratories in January, The Global Fund has refused to source anti-malarial drugs (Artemisinin based Combination Therapy, or ACTs) from the company. Ipca’s Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa) manufacturing units have been under the FDA scrutiny since July 2014, and the company has voluntarily stopped supplies to the US.

The move is a setback to Ipca Laboratories; antimalaria drugs accounted for 24% of its formulation exports in 2015. According to Edelweiss Securities analysts, The Global Fund accounts for about 70% of Ipca’s total institutional business in Africa. It said the Ipca management had indicated that the remediation measures at its plants would be completed within six months and that Global Fund shipments would resume soon. However, this has not happened.

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