Below is a selection of the top stories in Indian pharma from recent months, ranging from efforts to counter the coronavirus, to regulatory reform, the spike in USFDA warning letters to Indian pharma manufacturers, promising export markets, and the growth of the Indian domestic market.
Repurposing HIV drugs to fight coronavirus
Indian firm Cipla has announced that two of its antiretroviral medications – lopinavir and ritonavir – may be utilised to combat coronavirus. Lopinavir and ritonavir, now off-patent, are protease inhibitors designed to block HIV viral replication and have been around for more than 10 years. Cipla is ready to supply the medicines if called upon, and reports they are approved in China and the US.
Indian firms hope regulatory turmoil will subside in 2020
Indian pharma has faced a difficult few years with regulatory issues. In 2013 the National Pharmaceutical Pricing Authority (NPPA) issued the so-called Drug Prices Control Order which gave regulators the power to control the prices of drugs not on the National List of Essential Medicines. With this power, the NPPA was able to put a cap on certain products, which led to turmoil and unpredictability. This past December the NPPA made a pricing revision to increase the ceiling prices of 21 formulations by 50 per cent. Indian firms hope the pricing revision, along with the soon-to-be-published List of Essential Medicines 2020, will boost revenues in the coming year.
USFDA warning letters to Indian pharma on the rise in 2019
19 warning letters were issued to Indian pharma companies out of the 41 total letters issued by the Office of Manufacturing Quality of the US Food and Drug Administration (USFDA) in 2019. After a period of relative decline in warning letters, thanks to Indian companies increasingly complying with standards and resolving manufacturing quality issues quickly, the spike in 2019 is the highest amount in four years. Most warning letters from the last year were based on inspections from the prior year analysing the progress of remediation.
Growth in the Philippine pharma market means new opportunities for India
Thanks to the implementation of the Philippines’ newly implemented Universal Healthcare Act, the Philippine pharmaceutical market is projected to grow to reach USD 4.76 billion by 2025. This growth presents a unique opportunity for Indian pharma, as it was reported to be the top import partner of the Philippines in 2018, contributing 12.6 percent of the total pharmaceutical imports into the country. According to the Indian Embassy in Manila, India’s pharmaceutical exports to the Philippines increased from USD 197.32 million in 2017-18 to USD 220.98 million in 2018-19.
Indian domestic pharma on the up in 2019
2019 was a boom year for the Indian pharma market. Despite regulatory hurdles and USFDA warning letters, the domestic pharma market reported more than 11 per cent growth in the second quarter of 2019 and over 14 per cent growth as of November. Profits soared at some of India’s biggest pharma firms, with Dr Reddy’s, Torrent and Sun Pharma all reporting double digit growth.
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