Centre to lay down vaccine trial norms
Why in news?
The government is readying a document that will lay down guidelines for companies and institutions working on potential COVID19 vaccines.
Who will be issuing?
This will be issued by the Central Drug Standards and Control Organisation.
Vaccines from India:
There are five promising candidate vaccines from India. Prominent among them are:
- Covaxin from Bharat Biotech
- ZyCoV-D from Zydus Cadilla (cleared by the Drug Controller General of India for early human trials)
Steps in Vaccine Approval:
The general stages of the development cycle of a vaccine are:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
Clinical development is a three-phase process:
- Phase I: small groups of people receive the trial vaccine.
- Phase II: the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
- Phase III: the vaccine is given to thousands of people and tested for efficacy and safety.
Some Ground rules:
- The vaccine candidate should not sicken a healthy person. Hence, a weakened form of the virus is introduced into healthy volunteers.
- The next step is getting the vaccine to stimulate the immune system to get it to produce antibodies.
- Finally, only if all were to go well, it must be tested on many people in real-world conditions.
- Gradually, they are expected to be better protected compared to those who were unvaccinated.
- Rushing any of these phases can backfire and be fatal.
- Each step is very important to ensure that the vaccine can be released for the masses.
Drug Controller General of India
- DCGI is a department under the Central Drugs Standard Control Organization.
- It is responsible for the approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.
- DCGI lays down standards and quality of manufacturing, selling, import, and distribution of drugs in India.
- It acts as appellate authority in case of any dispute regarding the quality of drugs.
- It prepares and maintains national reference standards.
- It brings about uniformity in the enforcement of the Drugs and Cosmetics Act.
- It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
Central Drug Standards and Control Organisation:
The Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
Under the Drugs and Cosmetics Act, CDSCO is responsible for:
- Approval of Drugs
- Conduct of Clinical Trials
- Laying down the standards for Drugs
- Control over the quality of imported drugs in the country and
- Coordination of the activities of State Drug Control Organizations by providing expert advice with a view of brings about uniformity in the enforcement of the Drugs and Cosmetics Act.
Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.
- No process in vaccine development trials would be skipped
- Different phases of the trial can be conducted in parallel to speed up the process.
- No phase can be skipped but regulators can give approvals to two phases together.