New Delhi: India’s drugs regulator is looking to monitor the quality and efficacy of bulk drugs imported into the country after recent seizures in Mumbai and Chennai which indicate that some importers are looking to evade import duty, bypass import regulations, or actually importing so-called spurious drugs in an effort to cut costs.
The regulator is also looking to send inspectors to countries from where India sources bulk drugs in an effort to monitor quality, although a pharma industry representative said such inspections were contingent on the cooperation of regulators and manufacturers in those countries.
The proposal is to send inspectors to China, Korea, Vietnam, the UK, the US and other countries from where India sources bulk drugs, said Surinder Singh, drugs controller general of India (DCGI).
Safety practices: The Drugs Controller General of India will tighten its monitoring of bulk pharma imports in an attempt to prevent the import of so-called spurious drugs. Hemant Mishra / Mint
Bulk drugs are raw materials that go into the making of formulations or medicines. India currently imports 60-70% of its bulk drugs requirement. Inspections such as the ones proposed by Singh are commonly carried out by regulators in the US and the EU, but India has never conducted them before.
“Everyone comes and audits our units—the European regulators, the US regulators—but we never go and routinely audit units and see what type of facilities and regulatory mechanisms are being followed so that we can assure (ourselves of) the quality of production of the products which are coming in,” Singh added.
The regulator also plans to work closely with the customs department to prevent companies from evading import tariffs—much like two recent efforts to do so by importing drugs under their chemical names to “avoid registration and import duty”, according to a senior official at the regulator’s Mumbai office. The official, who did not want to be identified, said in both instances, the regulator has asked the customs department to confiscate the drugs.
The regulator’s plan has been welcomed by companies here. “It has been a long-standing demand of SME Pharma Industries Confederation (SPIC) to tighten the registration procedure of import of APIs (active pharmaceutical ingredients, or bulk drugs) in order to weed out the manipulations occurring in (the) absence of verifications and inspections of plants, not only in China, but also in the developed countries in interest of safety, health and efficacy of the Indian public,” said Lalit Kumar Jain, senior vice chairman, SPIC, an industry body.
“India imports 60-70% of its bulk and intermediate drugs. .... If our people go there to inspect facilities abroad then that will be ideal. But we need to see if the authorities there will allow such inspections,”added Ranga Rao, executive director, bulk drug manufacturers association of India.
Separately, in an attempt to address the looming problem of spurious drugs, DCGI, which initiated a study on the issue last year, has collected 24,000 random samples with the help of activists. These are now being analysed and the results are expected in a month. The study has been designed by the Indian Statistical Institute of Hyderabad.
The regulator, however, is handicapped in its efforts due to the absence of enough government laboratories that are accredited to test drugs and will only publish the results of its tests of 10,000 samples in the first phase.
Singh, who said he eventually plans to study 100,000 samples, added that he is pushing for an amendment in the Drugs and Cosmetics Act that will enable DCGI to work with private laboratories to test the drugs.