The Central Government has relaxed the rule that necessitates local clinical trials for five categories of new drugs if those drugs are already approved and marketed in the US, UK, Japan, Australia, Canada, and the EU.
In an order issued on August 7, the Drugs Controller General of India (DCGI) has stated that the categories of drugs which are eligible for this concession are orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defence purposes, and new drugs offering significant therapeutic advances over the current standard care.
The move will reduce the time gap between the launch of new drugs by global multinational pharmaceutical companies in these developed markets and in India.
The DCGI order stated that the New Drugs and Clinical Trials Rules (NDCTR) 2019 empower the regulator to make such concessions if deemed necessary.
According to Rule 101 of NDCTR-2019, the Central Licencing Authority (office of the DCGI), with the approval of the Central Government, may specify, by order, the name of the countries, from time to time for considering a waiver of local clinical trial for the approval of new drugs under Chapter X (which lays down the rules for the import or manufacture of new drugs for sale and distribution in India) and for granting permission for conducting clinical trials under Chapter V (the section that deals with the rules to be followed for conducting clinical trials, bioavailability, and bioequivalence study of new drugs and investigational new drugs).
The NDCTR-2019 says that a local clinical trial may not be required if the new drug is approved and marketed in such specifically mentioned countries, if no major unexpected serious adverse events have been reported or the application is for import of a new drug for which the Indian regulator had already granted permission to conduct a global clinical trial which is ongoing in India, and in the meantime, the new drug has been approved for marketing in a country specified under rule 101, and if there is no probability or evidence, on the basis of existing knowledge, of differences in the Indian population of the enzymes or genes involved in the metabolism of the new drug, or any factor affecting pharmacokinetics, and pharmacodynamics, safety, and efficacy of the new drug.
