New Delhi – India is fastest growing economy in the world and trend setter in all front in global arena but CDSCO is follower of US FDA, UKMHRA and other EU agency. We are least 10 years back in comparison to US FDA, UKMHRA and other EU agency because continuously we are following them.
The move comes amid growing concern about the quality of medicines made in India and demands for a tighter inspection mechanism by regulatory agencies. The inspections by India’s drug regulatory agency could begin in a month’s time, said the official.
Stung by US and European regulators finding fault with Indian plants, the Central Drugs Standard Control Organization (CDSCO) will soon start surprise checks at manufacturing sites. The move, along the lines of the inspection process of the US Food and Drug Administration (FDA), is part of an exercise to ensure the local market isn’t flooded with substandard medicines, a health ministry official said
An aggressive surveillance and enforcement system will help the government’s drive to weed out drug units that may deviate from standard manufacturing practices thus compromising patient safety. Schedule M of India’s Drugs and Cosmetic Rules 1945 lists the requirements for good manufacturing practices (GMP) certification and the Certificate of Pharmaceutical Products as per WHO guidelines.
Those deviating from quality standards face punishment. “We may even issue suspension or cancellation of licences. In cases of major deviations, we may also (take legal action) against the company,” said the official. Indian regulators haven’t been as harsh as the FDA and other international agencies against local manufacturing facilities.
CDSCO is also looking to strengthen its workforce to ensure frequent audits and wide coverage. The regulator aims to employ 1,000 people in various cadres at the Centre and state levels over the next three years. About 250 of them will be for the inspection wing.
This move of CDSCO is absolutely incomplete and meaningless unless until all distribution point should follow the storage and other standard as per Drug and Cosmetic Act. In India temperature sometimes cross more than 50 degree Celsius but commonly temperature remains 40 to 48 degree Celsius across the country in summer.
I have seen distribution point and pharmacy standard in other part of the world. When I compare with current Indian standard it shows that regulator are not serious for safety of drug. Cartons remain in sunlight in most of the distribution point, forget air-condition. In this case light sensitive product will deteriorate and will be poison. Mostly Pharmacy in across India is without air condition.
Alone manufacturers are not responsible for quality of medicine. Manufacturers along with all distribution point are equally responsible. Please do something to make all distribution point near to global standard.