Report Calls for Measures to Preserve India’s Brand in Global Pharma Market

A new report to the government of India suggests the adoption of a slew of measures to help domestic pharma firms, especially small firms that form the bulk of the industry, better understand the global regulatory landscape and meet compliance standards in advanced countries.

The report comes in the wake of a number of drug quality issues raised by the FDA after a series of inspections. Those issues, often linked to a handful of manufacturers in a field of thousands, can hurt the entire national industry, one that is among the largest in the world.

India’s pharmaceutical industry should understand that the entire “brand India” suffers from irregularities observed by international authorities in the products of a few Indian companies, Krishna Ella, founder of Hyderabad-based Bharat Biotech, which unrolled the world’s cheapest rotavirus vaccine in March, told BioWorld Today. Ella said most of the problems in the case of Indian drug firms arise from a lack of stringent documentation during the manufacturing and testing process.

“Data integrity is the root cause of all issues being faced by India,” he said.

A report released in June by Ernst & Young backs Ella’s view, saying data integrity issues persist in the Indian pharma industry. Data integrity, inadequate validation during manufacturing and testing, and cases of product contamination were among the issues that have come out during FDA inspections.

“The problems encountered by the FDA’s investigators in India are similar to those seen around the world in manufacturing,” said an FDA spokesman.

The FDA’s office in India, set up in 2008, works with Indian regulators, who have become “important strategic partners for the FDA” on a range of issues from clinical trials to product safety, which may impact U.S. consumers, he said.

He said the FDA India office ensures that Indian manufacturers shipping to the U.S. “understand the risk associated with their product’s processes,” are compliant with the FDA’s regulations, and food and medical products are safe and of high quality.

It is with all those goals in mind that a commission has put forth its recommendations in a report, titled “Recommendations of the Task Force on Enabling Private Sector to Lead the Growth of Pharmaceutical Industry.” India’s Minister for Chemicals and Fertilizers, Anant Kumar, recently announced the measures.

Among the key recommendations is the creation of a high-level coordination committee to periodically review the constraints that the pharmaceutical industry faces. Smaller companies are often handicapped by low levels of investment and limits on growth beyond their allocated space in industrial clusters with “antiquated environment standards.”

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