China likely to be Indian drug monitors first offshore pillbox

Written by Soma Das | New Delhi | Updated: Oct 8 2012, 09:27am hrs
The most sophisticated drug regulators of the world like the Food and Drug Administration (FDA) of the US are known to certify and inspect drug plants overseas, regardless of the local regulators. New Delhi seems to be following suit.

Indian diplomats posted in Beijing could soon have a new set of colleagues joining them drug inspectors from back home. This is because the government is readying a plan to permanently station officials from the Drug Controller General of Indias office in China, in all likelihood at the Indian embassy. These officials will undertake need-based inspections of the Chinese plants for manufacture of active pharma ingredients (APIs, or raw materials used in medicines).

The need for this and frequent inspections in Chinese API plants was felt as China has emerged as the source of over half of the bulk drugs used in the country and is also home to over 40% of bulk drug exporters registered in India.

Ensuring quality of APIs and checking that substandard bulk drugs do not make their way into India from China has become important as that forms the basis for the quality of drugs that our drug makers produce for the domestic market and exports, a health ministry official said. In value terms, drug imports from China to India soared to R4,424 crore in 2011, up from Rs 849 crore in 2004, according to Centre for Monitoring Indian Economy data.

Sources said that an audit team that inspected plants of four Chinese firms (three API facilities and one diagnostic plant) earlier this year in the second ever overseas inspection conducted by the DCGI has recommended cancelling the licence of one Chinese firm for non-compliance of good manufacturing practices. This firm was exporting the antibiotic cephalosporins to India and its licence would be revoked, the source added.

The new model, once firmed up, is likely to be replicated in setting up five such DCGI offices overseas over next five years in South Africa, Brazil, the US and a European site in addition to China. This entire exercise along with other overseas audits of manufacturing facilities should cost us close to R200 crore in next five years. The idea is to begin by placing drug inspectors, typically two to three at these overseas locations in the embassy itself, which would spare the initial headache of acquiring land for office space. And these inspectors would be stationed just like trade counsels, which work from the embassy premises currently, the official said.

This is exactly how USFDA began its operations in India, starting to function from the US embassy premises, he added. The USFDA set up its New Delhi base in 2008 and followed it up with an office in Mumbai in 2009, with a basic stated goal of ensuring that food and medical products exported from India to the US are safe and are of good quality.

The Indian drug regulators branches overseas are aiming to achieve three goals first, to ensure safety and efficacy of the raw material and drug formulations (end products) that are imported to India, the reason behind their plan to start the process by setting up a base in China, the largest source of APIs for India.

Second, a regulatory presence across the globe may deter and prevent the misuse of Indian brands. We have had bitter experiences in the recent past in Nigeria wherein fake drugs labelled Made in India were ultimately found to have originated from China. Having a regulatory presence would deter these activities and help bust such nefarious designs, the official said. Finally, as FE reported last month, the drug regulators scope, which is currently restricted to manufacture, import and sale of drugs in domestic market, is set to be extended to ensure safety and quality exports, with an amendment to the Drugs and Cosmetics Act expected to be introduced in Parliament in the winter session. These overseas branches are also likely to have a mandate to ensure the safety and efficacy of drugs of Indian origin.

Since 2011, the DCGI office has conducted two rounds of inspections in China. Last year, one Chinese firms refused entry to the Indian audit team and lost its import licence. For both rounds of audit, the Indian government had coordinated with China's drug authority, which in fact sent its own representative to facilitate the process of inspection. This initiative of overseas inspection was triggered by a development in 2009, when the DCGI's office for the first time nabbed local traders for importing and supplying substandard drugs from China.