Insight

Subject Expert Committee’s Updates

  • 30th August, 2016

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:

  1. To comprehensively advise on the assessments of non-clinical data such as toxicology data, pharmacological clinical trial phase I, II, III and IV data for the approval of:
    1. Potential new substances or new drugs of chemical and biological origin
    2. Novel medical devices particularly the ones that do not exist in the country such as vaccines or r-DNA derived substances
    3. Biological product approvals such as r-DNA products and vaccines that already exist in the country
    4. Fixed dose combinations of two or more drugs that are to be presented for the first time in the country
    5. Global clinical trials happening all across the world
    6. Procedural matters such as safety or root cause analysis when needed or when asked by the Ministry or Government requiring expert opinion
  2. To counsel and assist in the planning and preparation of guidelines for Clinical Research industry for developing the criteria for acceptance/rejection for the marketing of new drugs in different medical therapeutic categories.
  3. To recommend a roadmap of research to the pharmaceutical companies to manufacture new medications that cater to the Indian population
  4. To examine the utility and anticipated nature of new drugs in terms of the assessment of risk v/s benefits for patients, innovation of new drug based on existing drugs and the unmet need in the country
  5. To assist in any other matters that CDSCO needs advice on
  6. To evaluate the new drug applications and global clinical trials through meeting or video conferencing
  7. To submit their propositions and appraisals in writing within a period of 6 weeks from the receipt of the same
  8. To follow the regulatory framework in India when evaluating new drug and clinical trial proposals
  9. To be nondiscriminatory in the recommendations and present it in a amalgamated manner
  10. To maintain utmost discretion of the documents submitted by the applicants
  11. In case of a suggestion or revision from the initial proposal, the committee shall deliberate the meeting considering the initial decision
  12. The Indian government IPC budget will foot the requirement of the honorarium to be paid to the experts
  13. Each member will evaluate and give written expert comments within a time frame of 6 weeks of receiving the proposal, even if they cannot attend a particular meeting
  14. SEC will give its final opinion after the evaluation of the proposal within the regulatory framework and practical utility of the products.

 

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  1. Assisting the clients in understanding the recommendations from regulatory authorities, bridging the gap between the client’s mindset and expert’s mindsets.
  1. Preparation of scientific presentations to be presented during the SEC meetings.
  1. Our team consists of medical doctors and regulatory experts who have already attended several SEC meetings.
  1. Assisting during the meetings- presenting presentations, delivering it and answering the queries raised by experts, if any.
  1. Assisting with post-approval queries or changes post-document submission
  1. Thorough updates on latest regulatory guidelines and amendments to old guidelines