The import, manufacture, distribution and sale of drugs and cosmetics in India are controlled by the Drugs &Cosmetics Act, 1940 and The Drugs & Cosmetic Rules, 1945.
As far as cosmetics are concerned, they require licence for manufacturing. The licences are issued by the State / UT Drugs Control administration. The BIS lay down the standards for cosmetics. There are so many cosmetics for which standards are not made yet. No licence is required for the import, distribution or sale of cosmetics.
Control over drugs is the prime object of D&C Act. Drugs include all medicines and all substances intended for medicinal purposes. The Central Government can notify any substance or device as drugs. Rubber condoms, disinfectants, Copper T, Blood Bags, Disposable needles and Syringes, etc are such notified drugs. Still most of the medical devices are not notified so far, whereby they are manufactured and marketed without any control. As nutraceuticals, dietary/ nutritional supplements are not defined under any statute, all edible things come within the definition of either drug or food, under The Prevention of Food Adulteration (PFA) Act. As drugs are exempted from the definition of food and such exemption is not given for drug, even food marketed exclusively for medicinal purpose is considered as drug.
Still Central and most of the State Drugs Control officials, take a relaxed attitude in favour of manufacturers to exclude these items from their purview. Major part of Vitamin formulations, disposable needles like scalp vein set and IV Cannula, anticancer drugs filled inside DES in the market are no drug.
In addition to modern drugs, Homoeopathic and Ayurvedic drugs are controlled by the Act. No standards are fixed for Ayurveda and Homoeopahy drugs. For the manufacture, drugs licences are required.
CDSCO, headed by the Drugs Controller General of India (DCGI) working under Director General of Health Services (DGHS), having 4 zonal offices and 30-field force is the administrative wing of Central government. CDSCO is coordinating the state Drugs Control activities and issues import licences. Nowadays they are also joint licencing authority for LVP, blood banks and Vaccines.
Formerly import licences were required only for drugs specified in Schedule C and C1. Now all drugs require import licence and the manufacturer has to register before import. Obtaining such permit and licence
Granting licences for sale or manufacture of drugs, conducting periodical inspection of such premises are mostly the responsibility of state drugs control administrations. Each state does the functions independently. Any company granted a licence to manufacture drugs in one state can market anywhere in India.
The author is the deputy drugs controller, Kerala