The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is the Central Drug Authority for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act. […]
The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is the Central Drug Authority for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act.
Furthermore, CDSCO also plays a vital role in taking care of health services such as making committees of eligible members to review clinical trials in various scopes of practice such as ophthalmology, cardiology, pediatrics, psychiatry, and many more.
What is the Subject Expert Committee (SEC)?
The Ministry of Health and Family Welfare of the Government of India, through CDSCO, endorses 25 panels of experts from various therapeutic areas that come together to evaluate various categories of applications of clinical trials, new drugs, and medical devices. Experts are selected and approved by the government from various therapeutic fields of medicine all over the country.
SEC is one such committee formed by CDSCO. SEC comprises of 8 experts, whose names are drawn from the 25 panels; 7 of the 8 members need to be medical specialists whereas 1 has to be a pharmacologist. These experts need to be priorly approved by the Ministry of Health and Family Welfare. In case of the absence of an expert in a meeting, another member from the panel, having requisite specialization and experience, is invited to attend the meeting. Names of experts from various Govt. Medical Colleges or Govt. hospitals may be added if deemed necessary by the government or CDSCO.
What is expected from the experts of SEC?
The experts are expected to make essential statements and give advice to Drug Controller General of India (DCGI) on the upcoming clinical trials, drugs, and medical devices. The panel is held up to high standards to follow the national regulations, and the following are the specific rules that need to be adhered to:
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