Indian pharma firms compliance with USFDA norms improving of late

Indians and Chinese supply 80 per cent of active ingredients to the US and Indians alone are responsible for 40-45 per cent of finished dosages
While the recent book by investigative journalist Katherine Eban's  Bottle of Lies has raked up a dated controversy surrounding drug-manufacturing practices in India, the largest supplier of generic medicines to the US, the local industry here feels that they have been unfairly targeted. Even recent statements by the US Food and Drug Administration (US FDA) support the generic manufacturers in India and China. 

Moreover, recent data showed Indian drug exporters had been able to score with the US FDA and the inspection outcomes had improved — the number of cases classified as facility as ‘official action indicated’ (OAI) by the FDA has come down sharply.

Uday Bhaskar, director general of the Pharmaceutical Export Promotion Council (Pharmexcil), felt the inferences in the book were based on information of select cases and did not present the current situation. “In the book, Bottle of Lies written by Katherine Eban, the Indian pharmaceutical industry has been unfairly targeted. The book makes unsubstantiated, unqualified and unsolicited comments about select Indian pharmaceutical companies, based on out-of-date allegations from more than a decade ago,” the Pharmexcil said. 

Indians and Chinese supply 80 per cent of active ingredients to the US and Indians alone are responsible for 40-45 per cent of finished dosages. 

In a recent report on Eban’s book, IIFL analysts said, “Several Indian firms have had pristine track record in the past 5-6 years, the period that relates to the period of increased regulatory scrutiny pointed out in the book.” 

Speaking on grounds of anonymity, a leading drug exporter to the US said while there might have been lapses (which he attributed to lack of understanding of the regulatory environment in the US), in the recent years, manufacturing standards had indeed improved. “The industry came together to sit down with the US regulators to understand their requirements, especially related to documentation etc. Stringent quality assurance programmes have been thereafter implemented and compliance has indeed improved. The book has simply dug up the past which does not represent the current scenario," he said. 

The Indian Pharmaceutical Alliance (IPA), which represents the leading Indian drug manufacturers, seemed to agree. "The inferences in the book are dated, fed on half-truths and draw on historic information of select cases. These are far from the current situation," it said. Sudarshan Jain, secretary general of the IPA said the IPA had started an initiative to improve quality standards among Indian players three years ago. In 2016, six of the IPA's members — Cadila Healthcare, Cipla, Dr Reddy's Laboratories, Lupin, Sun Pharmaceutical and Torrent Pharmaceuticals — set up a forum to address the issues of data integrity and quality culture. The efforts seem to be paying off now. 

According to a study by the IPA and consultancy firm McKinsey, India had 6 per cent of the global inspections in 2014, which steadily increased to touch 14 per cent of the global inspections in 2018. Of the total 174 inspections in 2018 in India, only seven were classified as OAI, while 91 were classified as VAI (voluntary action needed)  and 76 as NAI (no action needed).  This is a significant improvement from previous years - in 2017 the numbers were as 22 OAI, 80 VAI and 43 NAI, respectively.

In a February 22 statement, former FDA commissioner Scott Gottlieb said FDA's rigorous standards and inspections apply equally to generic and brand drugs — whether the medicines are being manufactured in Shandong, India, or Indiana. The statement futher said FDA's inspectional footprint is robust, particularly in China and India. 

“The FDA’s standards and inspections for generic manufacturers are the same around the globe. Pharmaceutical manufacturers, no matter where they're located, are responsible for ensuring high quality products reach US patients," Gottlieb noted, adding "For example, the FDA labs tested 323 products from around the world — including more than 100 from India — to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met US market quality standards using testing standards set by the United States Pharmacopeia or submitted in marketing applications.”

The US market for pharmaceuticals has changed dramatically recently. In 1990, generic medicines only accounted for 33 per cent of retail prescriptions. Today, generics account for 90 per cent. Supply chains have also expanded globally. This has created new complexities, and new opportunities for novel risks, the FDA felt.

India: Pharmacy of the world

  • Supplies drugs to over 200 countries
  • The Indian pharma industry accounts for 10 per cent of global pharma output in terms of volume, 3 per cent in terms of value
  • 55 per cent India’s exports are to highly regulated markets
  • USA is the largest exporting partner of lndia. In US, generic drugs account for 90 per cent of retail prescriptions. 40 per cent of generics marketed in US are from India
  • India accounts for about 37 per cent of Drug Master Files filed with the US
  • There is a substantial rise in share of US FDA ANDA approvals for Indian firms from 26 per cent in 2011 to 38 per cent in 2018


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