The central drugs and standard control organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare, and Government of India is the National Regulatory Authority (NRA) of India.
Under the Drugs and Cosmetic Act, CDSCO has many responsibilities which include approval of Drugs to direct clinical trials, Providing standards for drugs, quality check imported drugs in the country, and coordinating with the state drug control organization for the activities by providing expert advice, training keeping in mind the uniformity in the implementation of the Drugs and Cosmetic act.
Also, CDSCO regulates the manufacturing and import of medical devices in India. As per the Drug and Cosmetic Act, medical devices are categorized under the category of drugs.
Role of Central Drug Standard Control Organization:
Under the Drug and Cosmetic Act, the arrangement of manufacture, sale, and distribution of Drugs, medical devices,s, and cosmetics is firstly the priority of state authorities while central authorities are only responsible for giving permission to new drugs, clinical experiments in the country, providing standards for drugs, to check the quality of the imported drugs, coordinating with the state authorities.
CDSCO is also a part of giving permission to specified categories of drugs such as blood and blood products, I.V Fluids, Vaccines
What is a Medical Devices?
According to the latest definition as provided under the Medical Devices Amendment rules 2020, as notified on 11.02.2020. However, taking care of circumstances the government has exercised its powers to include more categories by widening the scope of the definition of “Medical Device” under the Act. It states-
"Devices used in general medical practice such as medical apparatus, instruments, implants appliance, etc., which are either used individually or in combination, and are intended to be specifically applied for human beings or animals and are further intended to obtain the desired function by such means and for such purposes as provided below, but is not intended to meet the primary intended action on human body or animals by any pharmacological or immunological or metabolic means-
- Analysis, prevention, observation, treatment, or mitigation of any disease or disorder;
- Analysis, observation, treatment, mitigation, or support for any injury or disability;
- Examination, replacement or alteration or support in findings of the anatomy or a physiological process;
- For supporting or sustaining life;
- Decontamination of medical devices; and
- Conception-related equipment & devices.
Therefore, every manufacturer or importer or both of any medical devices in India shall be required to obtain registration as per the provisions of the Drugs and Cosmetics Act 1940. Any failure to comply with the same may invite legal action including penalty & prosecution under the Act.
Moreover, CDSCO along with state drug control organizations is together responsible for the permit of a license of certain specialized types of critical drugs.