India cracks down on pharmaceutical firms

face suspension or even cancellation of their licence.
These drug firms would have to update the DCGI on “how safe the drug has been” in the Indian context every six months for the first two years and once every year in the third and fourth year of the drug launch.
They are required to submit a periodic safety update report (PSUR) to the government. What triggered this new regulation were reports that while their licences were still pending, some pharmaceutical companies have been marketing their unsafe products in rural areas among illiterate villagers and making a fast buck.
“Many firms were also carrying out experiments on gullible patients and there have even been reports of distilled water being marketed as drugs for patients suffering from tuberculosis in rural areas.
These are efforts on part of the drug regulator to tighten the “post-marketing surveillance” in the US$10,9 billion Indian drug market, a mechanism used in the regulated markets to zero down on adverse side-effects a new drug may cause on people after it has hit the market.
These reports usually form the basis of decisions taken by drug regulators in developed countries to weed out some new drugs in cases where adverse effects outweigh therapeutic benefits or add caution and warning messages in the leaflets if hitherto unknown side-effects are discovered in a new drug.
While the global counterfeit drug market is estimated to be around US$75 billion, in India it is much more and is estimated to be around 20 percent of the total US$1,18 trillion pharmaceutical market or US$236 billion.
Pharmaceutical companies are now also mandated to reveal information to the drug regulator on which other countries the drug has been authorised to be marketed in or countries they have been banned, update of actions that have been taken for safety reasons in case of the drug, individual case histories and studies on the drug and supplement it with an overall safety evaluation in context to India.
The Indian drug regulator’s office on an average receives close to 1 600 applications related to new drugs every year.
By definition, a “new drug” under law is a molecule which is introduced for the first time in the country, an already approved drug proposed to be marketed for new usages or different indications or on a new delivery platform, or fixed dose combination drugs. The government in 2011 put in place a pharmaceutical vigilance programme, an adverse drug effect monitoring mechanism with All India Institute of Medical Sciences as the centre supported by hospitals and medical colleges across India. — Xinhua.