SEC Meetings

SEC Meetings

In order to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of drugs an Expert Committee was constituted by the Ministry of  Health & Family Welfare. The Expert Committee submitted its report to the Ministry of Health & Family Welfare. The actions proposed to be taken on the recommendations of the Expert Committee were finalized by the Ministry of Health & Family Welfare.

As per the report, following actions were amended –

• The New Drug Advisory Committees (NDACs) was renamed as Subject Expert Committee (SEC).
• A panel of experts shall randomly select the members for the meeting.
• The Subject Expert Committee shall evaluate the applications of clinical trials and new drugs for their safety and efficacy of products. Based on the recommendation by the SEC members regulatory authority approve applications. In case of not recommended applications, if applicant is not satisfy with the decision, then applicant can approach to Technical Review Committee (TRC) for review of safety and efficacy of data.
• The TRC shall be constituted under DGHS which consists of  experts from each fields i.e. clinical pharmacology, regulatory clinical toxicology / pathology , medicinal / pharmaceutical chemistry, pharmacy and immunology including clinicians, basic scientists involved in drug development and subjects specialists (drug indication wise).
• Clinical Trial and New Drugs shall get approval by CDSCO based on the recommendations by TRC.

There are 25 SEC Committees that are constituted as under:

1. SEC- ANALGESIC
2. SEC- ANESTHETICS
3. SEC- VACCINE
4. SEC- HEPATOLOGY
5. SEC- DENTISTRY
6. SEC- NEUROLOGY
7. SEC- PSYCHIATRIC
8. SEC- PEDIATRIC
9. SEC- GYNAECOLOGY
10. SEC- PULMONARY
11. SEC- ONCOLOGY
12. SEC- HEMATOLOGY
13. SEC- CARDIOLOGY
14. SEC- UROLOGY
15. SEC- NEPHROLOGY
16. SEC- ANTIVIRAL
17. SEC- ANTIMICROBIAL
18. SEC- RHEUMATOLOGY
19. SEC- ORTHOPAEDIC
20. SEC- GASTROENTEROLOGY
21. SEC- RADIODIAGNOSIS
22. SEC- OPTHALMOLOGY
23. SEC- DERMATOLOGY
24. SEC- ENDOCRINOLOGY
25. SEC- PHARMACOLOGY

The DCG(I) shall invite an expert who has an experience in that particular area of specialization required by SEC, pertaining to the specified application. The DCG(I) may add names of experts from Govt. Medical Colleges / Hospitals or eminent persons in the panels wherever necessary through a standard procedure.

Subject Expert Committee (SEC) comprises of 8 medical experts (01 Pharmacologist and 07 medical specialists) shall be constituted to select names of the experts from the respective panels approved by the Ministry. If an expert fails to attend the SEC meeting, another expert from the same panel shall  be invited to attend the meeting.