There are various authorities at central and state level to regulate or to deal with matters relating to drugs and cosmetics under the Drugs and Cosmetics Act, 1940 and rules, 1945. As per the Act, The Central Drugs Standard Control Organization (CDSCO) is the central authority responsible for bringing about transparency, accountability, and uniformity in its services to ensure that the medical products manufactured, imported, and distributed in the country are safe, efficient, and at par with the quality standards.
CDSCO, under the Ministry of Health and Family Welfare, is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, controlling the quality of imported drugs into the country and also coordinating the activities of the State Drug Control Organization by giving expert advice on related matters. The body is in charge of approving licences for specific types of drugs. Headquartered at Delhi, It has under its control 6 zonal offices, 4 sub-zonal offices, 13 port offices, and 7 laboratories. CDSCO is headed by the Drug Controller General of India (DCGI), who regulates the standards for medical and pharmaceutical devices and also establishes standards for manufacturing, sales, import, or distribution of drugs in India.
As such, the main functions of the CDSCO include the following:-
- To approve drugs as per the provisions under the Drugs and Cosmetics Act
- Conducting clinical trials
- For setting up standards for drugs, cosmetics, diagnostics, and devices,
- To have quality control over the drugs imported into the country.
- To coordinate the activities of the state drug control organizations,
- To deal with the registrations of foreign manufacturers of drugs and medical devices whose products are to be imported into the country,
- To grant licences for government hospitals or medical institutions to import drugs for the use of their patients.
- To lay down regulatory measures, amendments to Acts and rules
- Also, under section 26A of the Drugs and Cosmetics Act, to recommend the prohibition of drugs deemed harmful or sub-therapeutic.
- Publication of the Indian Pharmacopoeia.
In terms of who must obtain a license, importers, Indian agents, foreign enterprises with Indian subsidiaries, and corporations can register with CDSCO.The registration under CDSCO is necessary for registration of cosmetics, import or manufacture of drugs, export NOC, test license, ethics committee registration, formulation of R & D Organization, blood bank registration, dual use NOC (Tender), BA/BE approved sites, and for sponsors (BA/BE and CT). In simple terms, any organization that imports or manufactures or exports drugs and cosmetics, conducts R & D activities concerning drugs, is engaged in importing drugs for the purposes of testing, or conducts bio-availability (BA) and Bioequivalence (BE) studies on drugs for export purposes is required to register under CDSCO.
CDSCO is an important regulatory body in India for pharmaceuticals and medical devices and is the equivalent of the FDA in the USA. It is responsible for the enforcement of the Drugs and Cosmetics Act and providing expert advice on health issues. It works tirelessly to ensure the safety and well-being of the patients. It also plays an important role in granting licences for certain specialized categories of special drugs such as blood and blood products, I.V fluids, vaccines, and sera.
CDSCO works with the Drugs Technical Advisory Board and the Drugs Consultative Committee to regulate imported drugs; on the other hand, the Central Drugs Laboratory undertakes testing of such drugs.
The registration process is entirely online and the following are the documents required for registration under CDSCO:
- ID proof
- An undertaking issued by a government authority
- Address Verification Document
- In the case of BA/BE approved site registration, a copy of the BA/BE site registration as approved by CDSCO
- Manufacturing licences or wholesale licences in the case of the import or manufacture of drugs/blood product registration/test licence registration.
The Indian pharmaceutical industry is one of the largest in the world and its products are exported to most countries across the world, including highly advanced and regulated countries such as the USA, Europe, Japan, etc. Growing at a rapid pace, India’s pharmaceutical markets are attracting some major global companies. Therefore, proper and efficient regulation of the pharmaceutical industry is crucial, and CDSCO is the principal regulatory body in India to maintain the safety, efficacy, and quality of medical products.
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