Drug Regulator Teaming Up To Re-Inspect Manufacturing Plants Of Pharma Cos In Next Three Weeks

Drug Regulator Teaming Up To Re-Inspect Manufacturing Plants Of Pharma Cos In Next Three Weeks

New Delhi, 11 Jan 2018: 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 central 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 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 official.


State authorities will take action that includes suspending or cancelling licences for these plants in case they are found noncompliant the second time around, the official added. This is different from the first round of inspections, where firms found noncompliant 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, the official added.


“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. 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.ET Health World