Will USFDA'S new proposals help Indian pharma companies?

Fri, 20 Mar Pre-Open

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The spate of import alerts, warning letters on the Indian pharma manufacturers by US Food and Drug Administration (USFDA) have been increasing over last few years. More recently, there have been just few companies who have received clear chit post USFDA inspections. Majority of the Indian pharma players have been receiving 483s, since the USFDA does not find the facilities completely compliant with the norms. While such 483s do not hinder the company's growth, however they are negative, indicating the plant in question is not completely compliant with the norms.

This has raised concerns among stakeholders, as it has also strained trade relations between the two countries given that pharma is a crucial industry for both. After such bans, the US regulators are looking to improve drug quality and safety. A team of officials from the USFDA has come down to India, and is working on the progress made by the domestic drug regulator in ensuring quality of drugs. In 2014, USFDA commissioner Margaret Hamburg had visited India and more recently, Howard Sklamberg deputy commissioner for global regulatory and policy is in India.

As per Mint, after a three member delegation talks with Indian government officials, the USFDA yesterday announced that it is looking to adopt an incentive and regulations based policy in India. The regulator will be working towards ensuring higher levels of compliance, training and adoption of systems and procedures. Further, it will also expand its operations. The USFDA proposes to adopt 'carrot and sticks' approach from now. They are expected to sign memorandum of understanding on this too.

Reportedly, the US agency will be developing a matrix for ranking Indian companies and further use enforcement tools so that good manufacturing practices (GMP) are followed. At the same time, the regulator will also offer incentives for areas where the company has been following all the GMP norms. Hence as per the metrics, if a firm has high commitment to quality, the inspection will be lesser for such a company. As per Mr Sklamberg, they are working towards increasing more workshops for the Indian companies.

It is pertinent to note, India has built a large base of USFDA approved facilities in the country. Further, US is a major export destination for Indian pharma companies. Approximately 40% of their revenues are estimated to come from the sales in US market. Given the increasing volumes of drugs from Indian companies in the US market, the regulator is looking to have an efficient system in place, which in turn would assist the companies in enhancing the GMP norms. Hence, companies which are vigilant enough and follow all fair practices will remain ahead in the curve.