A drugs regulator is among the first to ad mit that oversight of India’s huge pharmaceutical industry can be patchy.
GL Singhal, chief regulator of Haryana, a drugs manufacturing hub, says he needs to double the number of inspectors if he is to properly scrutinise factories there.
‘‘We literally have skeletal services. We are struggling in the present system. Inspectors are so overburdened, and their nature of duty is very serious,’’ Singhal told Reuters.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India, where one in every 22 locally made samples was of sub-standard quality according to a study carried out two years ago.
These factories supply medicines for 1.2 billion people as well as export drugs to nearly 200 countries. Indian companies produce more than 20% of the world's generic drugs, according to PricewaterhouseCoopers.
Yet, many inspectors lack vehicles to travel to sites or sufficient space to store seized products. Moreover, former inspectors have told Reuters of lax procedures where bad practices are simply ignored.
Industry and former government officials also point to policy loopholes and the lack of a single strong regulator as serious problems.
Singhal's challenges in Haryana expose the weakness of oversight in a $14 billion drug industry that has already been hit by a rash of sanctions by the US Food and Drug Administration (FDA) due to lapses in manufacturing processes.
At a Ranbaxy Laboratories (RANB.NS) plant in Toansa, FDA inspectors said in January they had found that staff re-tested raw materials after they had failed analytical testing ‘‘in order to produce acceptable findings’’. In 2012, FDA inspectors at another Ranbaxy plant found a black fibre in a tablet that may have been a hair from an employee's arm.
But the vast majority of Indian drug plants are not inspected by the FDA and are instead overseen by state and national regulators which are plagued by a shortage of staff and funds and must work through the country's slow-moving judiciary to bring enforcement actions.
Of 48,082 drug samples collected by state inspectors in the year to March 2012, 4.5%, or 2,186, were found to be of sub-standard quality, according to a leaked confidential government document that has been published on the Internet. The document, published last year, said legal proceedings were launched in 211 of those cases.
Court cases brought against local companies over drug quality take up staff time and can drag on for years, during which the manufacturers can