Drug regulator teaming up to re inspect manufacturing plants of pharma cos in next three weeks
India's drug regulator is gearing up to re-inspect manufacturing plants of several pharmaceutical companies across the country to ensure they have taken measures to improve the quality of medicines sold here and exported to other markets. The re-inspections, which will see the centre and state drug regulators teaming up again, are expected in the next three weeks and may see punitive action against firms not complying with prescribed good manufacturing practices (GMP).
These inspections come at a time when some of the largest Indian drug makers are still struggling with compliance procedures set by global regulatory agencies like the US FDA and Health Canada.
A joint team of central and state drug regulators will re-inspect 147 drug manufacturing plants scrutinised across India over the last two years during a risk-based inspection exercise, said a senior health ministry official close to the development. An additional 37 plants, mostly belonging to some of India's largest pharma companies, will be re-inspected just by state drug regulators because these plants were found lacking in only a few parameters in the first round of joint inspections, according to the officials.
State authorities will take action that includes suspending or cancelling licences for these plants in case they are found non-compliant the second time around, the official added. This is different from the first round of inspections, where firms found non-compliant were allowed time to plug deficiencies.
The official declined to disclose the names of the companies whose manufacturing plants will be re-inspected.
"The companies have submitted their compliance letters (after the first inspection), but further joint inspection for verification of compliance is required," the official told ET on condition of anonymity. The plants up for joint re-inspection belong to small and medium companies producing medicines in all categories, the official added.
The Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulatory body, initiated risk-based inspections in 2016 to weed out supplies of substandard drugs in the market.
CDSCO had circulated a GMP checklist modelled on World Health Organisation criteria that inspectors would use to measure the risk of producing substandard products. The regulator was checking for practices that included the plant workers' hygiene and qualifications and whether companies were adopting shortcuts in internal tests of their products, another senior health ministry official earlier told ET.
The government prioritised these plants based on how many of their products failed quality tests and complaints from state and foreign drug regulators, the official said, adding that the exercise would cut down medicine quality-related deficiencies here by 80-90%.
"The intentions are honourable, but the government should provide hand-holding in the form of financial and technical support if it wants the industry to live up to these standards," Deepnath Roy Chowdhury, President, Indian Drug Manufacturers Association (IDMA) told ET.
Small and medium sized drug makers would not only have to invest a "steep" amount on physical infrastructure, but would also have to spend much more in operational costs to ensure compliance with WHO GMP guidelines, he added.
"It is in the interest of patients that units not complying with even Indian GMP requirements are closed down after adequate warning," DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA).
"Several small companies would have to close down if the standards are made too strict," an industry executive told ET on condition of anonymity.