CDSCO Full Form is The Central Drugs Standard Control Organization (CDSCO). It is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Headquartered by FDA Bhawan, Kotla Road, in New Delhi, it has six zonal offices, four sub zonal offices, along 13 Port offices and seven laboratories which are vastly spread across the country. A thorough reading of the topic will be helpful for your upcoming UPSC exam.
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Importance of CDSCO
Under the Drugs & cosmetics Act,1940, approval of new drugs as well as conducting clinical trials, putting down regulations for cosmetics and drugs are implemented through this act.The aim of CDSCO is to be transparent, accountable as well as keep a uniformity in the services it provides. With state regulators, it takes the responsibility to grant licences of categories of specialized drugs which are critical like blood products, Vaccines and I.V. Fluids.
CDSCO and Its Divisions
In total there are 8 divisions under CDSCO. This will be important for UPSC 2022. Let’s look at it:
1. BA/BE: BA means Bioavailability. It is the amount of drug which takes place from an
BE means Bioequivalence of a drug product is achieved if its absorption rate and extent aren’t significantly different from those of the product references when they are administered at
the same molar dose.
2. Biologies: Biological products are medical products that are made up of natural sources. Just like drugs, we use some biologics to treat diseases. Rest biologics can prevent us from diagnosing diseases. Some examples of this section are vaccines, gene therapies and cellular therapies.
3. Clinical Trials: It means research studies done on people with the aim of evaluating a medical, surgical, or intervention behaviour.
4. Cosmetics: Under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, anything which is rubbed, sprinkled or sprayed, and applied to, the human body, beautifying, promoting attractiveness or altering the appearance, etc. is cosmetic.
5. DTAB and DCC: This section organizes meetings of the Drugs Technical Advisory
Board (DTAB)’ and ‘Drugs Consultative Committee (DCC). The team of DTAB and DCC give recommendations on the matters which arise out of the administration of the Drugs and Cosmetics Act.
6. New Drugs: Under Rule 122-E of Drugs and Cosmetics Rules, a new drug includes anything that has bulk drug substance or is a phytopharmaceutical drug. It has not been used in the country with the conditions prescribed. It hasn’t also been recognized as safe by the licencing authority mentioned under rule 21 for the proposed claims.
7. Import, Registration: This section looks after the importing as well as the registration policies.
8. Medical Devices and Diagnostics: These materials are used for vitro diagnosis, surgical dressings and for surgical staples as well.
Purpose of CDSCO Online Registration and Documentation Required
The registrations can be given by CDSCO for different purposes:
Cosmetics Registration, Import or Manufacture of drugs, Test License, Ethics Committee Registration, etc.
The below documents need to be attached while filling out the registration application on the official portal:
- ID and Address Proof,
- Undertaking issued by Government Authority,
- Copy of BA/BE Site Registration approved by CDSCO. In case of import, a Manufacturing or Wholesale Licence of Drugs/Blood Product Registration.
With the growing importance of CDSCO, its key facts as well as Isotretinoin apart from other topics have found their way into the UPSC syllabus Prelims. Regarding the Mains, the topics will mostly revolve around drugs misuse and methods of prevention to avoid the misuse of the drugs.
Over the years, CDSCO has had a great track record with the World Health Organization due to its good functioning. In future, it also plans to open an international office in Beijing, China.
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Frequently Asked Questions on CDSCO
What is Test License in CDSCO?
Test license is needed for examination purposes. It is a test or analysis of a drug in small quantities. If noted, it is prohibited under section 10 of the Drugs and Cosmetics Act and Rules.
How many drugs can be imported through a single form 11 license?
Only 10 drugs can be imported under this license.
What does CDSCO regulate?
Under the drugs and cosmetics act, this institution regulates the drugs approval and clinical trials. It also lays down the standards for usage of drugs and looks after the quality control of drugs that are imported in the country.