No clinical trials in India for new drugs

• 26 Mar 2019

• 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.