Step up quality standards, US, EU regulators urge Indian drug companies

Mumbai: US and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry.

India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been dogged by concerns over quality issues after the US Food and Drug Administration (FDA) banned a series of factories from producing medicines for the United States due to inadequate standards.

The European Medicines Agency (EMA), and the UK’s Medicines and Health Regulatory Authority (MHRA) also barred some Indian plants from producing drugs for their markets.

Officials from the US, EU and UK regulators said they plan to increase the number of inspections in India, and are pushing for better cooperation between Indian authorities and companies as well as improved training for staff.

Some Indian companies are still not taking enough steps to identify risks and failures at their firms, said Russell Wesdyk, director of the office of surveillance at the FDA. “There is also a need to create a culture where employees can report bad news to their bosses,” said Gerald Heddell, the UK MHRA’s director of inspection enforc-ement and standards.

“There is a great respect for authority in India, but it can become a weakness if people close their minds and only listen to that authority, instead of doing the right thing,” he said.

India supplies about 33 per cent of the medicines sold in the United States, and nearly a quarter sold in the UK, according to a report released on Tuesday by the largest Indian pharma lobby group, the Indian Pharmaceutical Alliance (IPA).
Complaints from regulators have ranged from issues over hygiene and maintenance to concerns over falsifying manufacturing-related tests results and data.

Indian companies have said they have been working on improving their manufacturing standards by bringing in third-party auditors, training staff, and automating their systems.

The bosses of India’s largest drugmakers, including Sun Pharma, Dr Reddy’s Labs, Lupin and Cadila Healthcare stood by those commitments on Tuesday.

Sun’s founder Dilip Shanghvi said he expected to automate systems at all of his manufacturing plants in the next three to four years.

Efforts by some Indian companies in the last couple of years to improve compliance have been “very impressive”, said Thomas Cosgrove, director at the FDA’s office of manufacturing quality.

Yet, many are lagging behind and need to do more, he said, especially in ensuring that data is not compromised. “Data integrity really sounds off alarm bells for us ... if you see data integrity on the surface, there is likely a lot going on underneath,” Mr Cosgrove said.