In India import, manufacturing, distribution and sale of drug is synchronized under Drugs and Cosmetic Rules 1945 (hereinafter refer as Act) and Drugs and Cosmetics Act 1940 and made there under. In the current scenario, finished formulations and mass drug (Active Pharmaceutical Ingredients) are synchronized under the said Act. Any material falling within the description of drug (Section 3b of the Act) compulsory to be registered previous to making an import into the state. Not just drug but the industrialized site ought to be indexed for import. If the medicine, is counted within the description of latest Drug (Rule 122 E of the Act), the novel drug endorsement is the condition for compliance of appliance for Registration or trade in of drug.
The appliance for Registration and import can be completed to the certifying Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, New Delhi by the limited Authorized Agent of the overseas manufacturer having whichever sale or manufacturing License or by the overseas manufacturers‘ possessing a comprehensive License in the country. The Drugs & Cosmetics Act, 1940 regulates the drug import license in India along with manufacture, sale and distribution of drugs in India.
The worth of export of pharmaceuticals and drugs has greater than before to Rs. 24,942 crores in 2006- 07 from approximately Rs. 22,216 crores in 2005-06. Though, the imports of pharmaceutical and medicinal commodities have been approximately Rs. 5867.3 crores (conditional) in the year 2006-07. Furthermore, growing number of Indian pharmaceutical companies have been achieving international authoritarian approvals for their manufacturing plants from agencies like MHRA (UK), USFDA (USA), MCC (South Africa), TGA (Australia), Health Canada, and various others. India has the biggest quantity of USFDA approved manufacturing plants for general manufacture. Most important Indian companies are now on the lookout for more Abbreviated New Drug Approvals (ANDAs) in USA in dedicated segments like cardiovascular, anti infective and central nervous system groups.
The most important activities conducted in the Pharmaceutical division of the subdivision communicate to the expansion of the pharmaceutical industry, that is, its exports, production, imports, pricing, R&D, duty matters, etc. There is an 'Export Promotion Cell' in the department that acts as a nodal organization in the subjects associated to export of pharmaceuticals. The unit brings together statistical data on import or export of pharmaceuticals in the nation as well as embark on promotional actions for the speeding up of selling it to other countries.
There is an involved administrative centre of the Division, recognized as 'National Pharmaceutical Pricing Authority (NPPA)’, which keeps a look after price revision/ fixation of pharmaceutical and erstwhile associated subjects. Generally, the role of NPPA is to:-
Enforce and implement the requirements of the Drugs (Prices Control) Order in agreement with the authority entrusted to itTransact with all officially permitted subjects arising out of the judgments of the AuthorityKeep an eye on the accessibility of drugs, recognize scarcities, if any, and to obtain corrective stepsMaintain or collect data on exports and imports, production, market share of companies, productivity of companies, etc. for formulations and bulk drugsRecruit the staff members of the Authority, in accordance with the rules and measures as formulated by the Government