The Indian Drug Manufacturers Association (IDMA) has urged the Drugs Controller General of India (DCGI) asking registration fees of Rs 15,000 to continue instead of Rs.2 lakh for 83 fixed dose combinations (FDCs) approved prior to New Drugs and Clinical Trials Rules 2019.
DCGI Dr V G Somani had issued a notice in August 2019 that manufacturers holding license from state licensing authorities (SLAs) for the 83 FDCs declared as rational from the list of 294 FDCs could submit their applications under New Drugs and Clinical Trials Rules 2019, which meant payment of fees of Rs.2 lakhs per application as new drug.
IDMA stated in a letter that DCGI had also earlier issued a circular in February 2019 informing that manufacturers holding license from SLAs for the 83 FDCs could submit their applications by paying fees of Rs.15,000 to CDSCO and obtain license from SLAs.
DCGI further issued a notice on December 5, 2019 informing that MSMEs would be required to pay only half of the fees specified in the Schedule under the new rules.
The Union health ministry has notified the drugs and clinical trials rules, 2019 with an aim to promote clinical research in the country.
These rules will be applicable to all new drugs, ethics committee and investigational drugs applicable for human use, bioequivalence studies and clinical trial in India.
The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
New rules have reduced the time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
In case of no communication from DCGI, the application will be deemed to have been approved.
DCGI will decide the compensation in cases of death and permanent disability or other injury to a trial subject.
The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries specified by the DCGI with the approval of the government.
Ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
It has been mandated that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator.
New drugs approved for use in select developed markets will be automatically allowed in India provided global trials includes Indian patients.
This waiver would also extend to drugs that receive these marketing approvals even while a trial is underway in India.
New rules has 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.