After taking action against drug makers in China for quality lapses earlier this month, the Central Drugs Standard Control Organisation (CDSCO) has turned its attention to other overseas manufacturers, including those in countries with stringent regulatory systems such as the US and European countries, the officials said on condition of anonymity. A proposal to this effect was sent to the health ministry late last week, one official aware of the development said.
The move comes at a time when Indian drug makers are still trying to improve the quality of their facilities that have been flagged by foreign regulators such as US Food and Drug Administration (USFDA) over the years.
ET has reviewed parts of CDSCO's proposal. There are over 28 manufacturing sites registered in India from the US, it said.
"Most of the registered sites manufacture critical formulations or critical new therapies which are not available in other countries because...they fall in high risk categories," it said. "Inspection of these facilities not only result in compliance to the Drugs and Cosmetics Act and Rules and it will also give exposure to our drugs inspectors to new technology adopted for the manufacturing and state of art facilities.
According to the proposal, the sites will be inspected if they have made substandard drugs, received quality complaints, or faced action by other regulatory authorities. The regulator has also proposed inspection of facilities that make "high risk" or "critical" medicines, and those from where India imports large quantities of antibiotics, anti-diabetics and hypertensive drugs.
Companies shortlisted for the proposed inspections include those making biologics and anti-cancer medicines, the official said.
India recently banned imports of active pharmaceutical ingredients (APIs) from six manufacturing plants in China after site inspections in October-November unveiled serious quality lapses, the official said.
India has conducted overseas inspections before, but the latest inspections will be more intensified and along the lines of the inspections in China, another health ministry official said. "Now everything will be scrutinised stringently," the person said.
This official said CDSCO would measure drug facilities in the US and Europe against World Health Organisation's good manufacturing practices (GMP). "It is in mutual interest," the person said. "Our motto is to improve the quality of medical products...it is possible if GMP standards are being followed."
India imports medicines like biologics, cancer medicines, drug intermediates for APIs and patented medicines from places including the US, European Union (EU) and China, said PV Appaji, former director general at Pharmaceutical Export Promotion Council of India (PHARMEXCIL). At the same time, there is no comprehensive data on how much of these drugs, like patented drugs, are imported into the country, he said.
Some industry experts said the regulators should first look at India's drug quality before inspecting facilities abroad.
"We want our drug regulator to first focus on the domestic industry to improve its compliance with the GMP standards," said DG Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents large Indian drug makers such as Sun Pharma, Dr Reddys and Cipla.
"Before we go to audit the formulation facilities in the USA, we need to ask if we have found defective or substandard products among the imported products. If so, what action, if any, have we taken?" he said.
Dinesh Thakur, the whistleblower who in 2013 exposed data manipulation issues at Indian drug maker Ranbaxy, said the regulator has a prerogative to inspect any facility it thinks is producing substandard drugs for consumption in India, but it should first make the risk-assessment of these plants public. "Given limited resources to improve the quality of our drug supply, CDSCO ought to tell us if the manufacturing facilities they plan to inspect have supplied substandard drugs to India and how they have established this fact," he said, adding that the regulator should also make public actions initiated to remove these products from the country's supply chain.
Meanwhile, the US is looking to cover more ground with its inspections in India. ET reported in December that audits of Indian drug making sites would rise significantly after the USFDA and eight European member states entered a pact in October 2017 that would allow the US to rely on data from inspections by EU regulators.