India’s pharma industry needs a credibility boost

India’s reputation as the pharmacy of the world has of late suffered some hard knocks on the quality front. The country’s drug exports stood at $24.5 billion last fiscal year and the overall market is around $42 billion. This sector has grown at a fast clip of 9 per cent per annum in the past decade and currently, around 3,000 firms operate 10,000 pharmaceutical factories making generic drugs (copies of branded medicines sold at a lower price), over-the-counter medicines, vaccines, and ingredients.

Nearly 40 per cent of over-the-counter and generic medicines sold in the US and a quarter of all medicines dispensed in the UK come from India, and it is a major supplier to Africa. The country supplies around two-thirds of antiretroviral drugs globally to fight HIV. However, the quality of medicines made in India has of late come under the cloud. One of the worst incidents was the recent death of children in Gambia in West Africa, allegedly due to cough syrup made in India.

The matter came to light in October and the World Health Organization flagged the issue. The Indian government and the Haryana government imposed a ban on Sonepat-based Maiden Pharmaceuticals, which manufactures cough syrup. The drugs were exported to Gambia in a single batch in December last year with a use-by-date of November 2024. The Gambian government had launched an inquiry and the report is still awaited. The death of 69 children in Gambia was a headline-grabbing incident, but it was not a oneoff case.

The quality of drugs manufactured in India has been called out many times, especially by the US authorities. In the latest instance a few days ago, drug majors Dr Reddy’s Laboratories and Sun Pharma announced that they were recalling different products in the US market that were made in their Indian plants. Dr Reddy’s is recalling a drug used to treat sneezing, and runny nose, while Sun Pharma is recalling a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease.

Last month, Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant announced they were recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration. Within India, Biocon Biologics, a subsidiary of the Kiran Mazumdar Shaw-led Biocon, is currently facing allegations of paying bribes to a Central Drugs Standard Control Organisation official to waive a phase 3 clinical trial of Insulin Aspart Injection. The company has denied the allegation and the investigations are on.

All this points to the fact that the Indian pharmaceutical industry is plagued with quality issues and weak regulation. Both the central and state governments need to work in tandem and take measures to ensure that the country’s regulatory system is strong enough to inspire confidence in the global market. The country can ill-afford to let a booming industry built over the years, which provides jobs to thousands, lose its credibility and ultimately the global market share because of a few bad apples.