Drug manufacturing quality standards push on in India

Gerald Heddell

Foreign regulators and domestic producers in India are stepping into the breach to help the country improve its quality-control standards that have been the target in recent months of warning letters and outright bans for manufacturing shortfalls and in some cases fraud.

The country earns at least $15 billion from drug exports and is considered the largest generic producer to the world, so any shortfall in quality control has huge ramifications for the country's revenues.

The Indian Pharmaceutical Alliance (IPA), which is made up of most of the domestic generic drugmakers, announced that it is planning to submit "data integrity guidelines" for companies that have been on the receiving end of U.S. Food and Drug Administration (FDA) warning letters and bans.

The country is also gaining some foreign help with Gerald Heddell, director of the U.K.'s Inspection, Enforcement and Standards, Medicines & Healthcare products Regulatory Agency, saying in a recent Business Standard report that the Britain was working "closely" with the Indian government to help improve drug safety.

Heddell said in the report that "India is a very important supplier of medicines to Britain" and that a memorandum of understanding (MOU) signed last year allows Britain and India to work together on sharing of information and collaborating to "ensure that medicines are safe."

Heddell said British regulators, like their U.S. counterparts, were concerned about Indian producers because of data reliability issues and cross-contamination issues, adding that "companies have responded" in many cases in positive ways.

British regulators are in India "almost every week" he added, but there were no plans to set up an office in the country.

Meanwhile, in India, the IPA said its initiative to improve quality standards was being done because most of the major drugmakers have been caught in the FDA trap, according to the report.

Some drugmakers are turning to automation to improve quality-control issues while others are focusing on training for employees. Others still are encouraging employees to speak up if they see quality control issues.

Image removed.D.G. Shah

"We have been in touch with the U.S. FDA for the past year and are discussing how the industry and regulators can work together to ensure supply of quality products," IPA Secretary General D.G. Shah told the Business Standard. The alliance has also called on the global consulting firm McKinsey to "prepare data integrity guidelines and suggest measures to improve quality across the sector," the report said.

FDA officials said Indian companies that had received warning letters should "carry out comprehensive evaluations and put in place remediation strategies" and also said companies should not use poor operating procedures to "make scapegoats of junior employees," the report said.

- here's the report from the Business Standard on Britain
- and another from the Business Standard on the IPA