India is not the only country with quality and compliance issues in drug manufacturing — it is a problem that plagues companies in other countries also, the US regulator said.
"Quality is not an Indian problem, but a global problem. India has not done very differently than US or Europe," Mathew Thomas, country director of the US Food and Drug Administration (USFDA), said at a rare gathering of regulators from around the world and top executives of India's pharma companies.
Building a strong quality culture, adapting quality metrics and demystifying data reliability issues were the broad themes at the Indian Pharmaceutical Forum. These are the thorny issues that brought companies under the scanner of overseas drug inspectors for non-compliance.
The forum was organised by leading drug makers including Sun Pharmaceuticals, Lupin, Torrent, Cadila and Cipla. It brought together regulators from the US FDA, the UK's Medicine and Healthcare Products Regulatory Agency, the European Medicines Agency and India's Drug Controller under one roof to share views on ways to fix the quality of drugs produced in India.
The US, which is the largest market for Indian drug companies, has been a tough slide as leading drug makers have come under FDA scrutiny for not following good manufacturing norms.
Gerald Heddell, Director of Inspection, Enforcement and Standards at MHRA, expressed concern over the qualification of staff at the ground level in pharma companies and raised issues about data integrity. Brenden Cuddy, head of the EMA's manufacturing and quality compliance service, said the idea of inspections is to broaden coverage and maximise resources by focussing on sites of highest risk.
The sternest speech was by Thomas Cosgrove, Director Office of Compliance at the FDA, who spoke about common deviations that companies make when it comes to data integrity. Some of the issues he raised were lack of controlled access to computer systems, deletion of data and back-dating. Cosgrove also warned companies not to shift blame to junior employees or fire people who were not responsible for creating the problems. "This will not help," he said.
Dilip Shanghvi, MD of Sun Pharma, told reporters that continuous engagement with the regulators will help raise the quality bar of the Indian drug industry. "We are working towards exceeding the FDA's expectations," he said.
Satish Reddy, MD of Hyderabad-based Dr Reddy's Laboratories, said there is a need for senior management to be involved in manufacturing. The CEOs also discussed setting up an institute to train pharma employees in best quality practices.
Source : economictimes.indiatimes.com