Governance
No clinical trials in India for new drugs
- 26 Mar 2019
- 3 min read
- Union Ministry of Health and Family Welfare has allowed waivers on conducting trials for new drugs in India in case the drug is approved and marketed in countries specified by — the Central Drugs Standard Control Organisation (CDSCO).
Regulation
- New drugs approved for use in select developed markets will be automatically allowed in India provided global trials included Indian patients.
- This waiver would also extend to drugs that receive these marketing approvals even while a trial is underway in India.
- Data generated(clinical trial) outside the country will be acceptable.
- Providing post-trial access of the drugs to the patients that require it have been defined for the first time.
- It removed a clause in the clinical trials that mandated the sponsor (the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of a patient.
- Now companies will pay the total amount once it is proven that the injury occurred because of the trial.
- Compensations in cases of death and permanent disability, or “other” injuries to a trial participant will be decided by Drug Controller General of India(DCGI).
- It removed regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well-regulated overseas drug markets.
Significance of New Rules
- It will end the unnecessary repetition of trials and speed up the availability of new drugs in the country.
- It will lower the cost of drugs.
- It will improve the ease of doing business for drug makers.
Criticism of new regulations
- India is a country of vast ethnic diversity and most of the trials are done in the West. There is need of bridging trials for ethnically diverse populations to check drug suitability population.
- Waiver should be only for drugs required urgently for national emergency.
- Proving injury due to the trial is problematic and it is prone to manipulation.
Central Drugs Standard Control Organisation (CDSCO)
- The CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
- Major Functions:
- Regulatory control over the import of drugs, approval of new drugs and clinical trials.
- Approval of certain licences as Central Licence Approving Authority
- Drug Controller General of India(DCGI)
- DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
- It comes under the Ministry of Health & Family Welfare.
