DGCI allows faster access to drugs approved globally

The Drug Controller General of India (DGCI) has passed an order waiving clinical trials for new drugs for rare diseases, gene and cellular therapy, new drugs in a pandemic situation, and new drugs for “special defense purpose.”

About the New Order of DGCI

• Legal Provision: The exemption to Clinical Trials  was included in the 2019 New Drugs and Clinical Trial Rules but was unutilised til now as The DGCI had not specified which countries’ approvals could be used to waive local trials.
  • As per the existing rule, a company must conduct a clinical trial in India even if the drug has been approved globally. The trial must be approved by a committee under the drug regulator. 

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• New Drugs and Clinical Trial Rules 2019: As per the Rules, Local clinical trials may not be required,
  • If a new drug is approved in specific markets
  • No major adverse events have been reported 
  • A global trial with Indian sites is ongoing
  • No evidence of the enzymes or genes in the Indian population affecting the drug’s safety and efficacy
  • The applicant has provided an undertaking to conduct phase IV trials.
• New Order: 
  • Regulatory clearances can be obtained by pharma companies to sell their products in India by demonstrating that their new drugs offer a “significant therapeutic advance over the current standard of care” 
    • Applying for Waiver: Any  drug currently undergoing clinical trials in India that has already been approved by these international regulators can reapply for this waiver
  • Approvals: The Drug has to be approved by regulators in any of six countries or regions ie. The United States, United Kingdom, Japan, Australia, Canada, and the European Union.
  • Monitor Side Effects: The drugs approved through this waiver mechanism have to carry out “Phase IV post-marketing surveillance” to keep a watch on any serious adverse events.
  • Review process: The DGCI’s Subject Expert Committee (reviews clinical trial data for approval)  will still have the authority to require a company to conduct a clinical trial (the reason should be given in writing)  if there is evidence available of the drug’s different efficiency levels  on the Indian population.
• Significance: 
  • Ease Access to Essential Medicines: The new rules will ease access to specific medicines available globally  and benefit patients with rare diseases or cancers with specific genetic markers.
  • Affordable medicines: The move will benefit the big drug manufacturers of the country as they don’t have to conduct local clinical trails now which significantly adds to their costs which can subsequently reduce the price of the products.
  • Availability of Blockbuster Drugs: The move will accelerate the availability of drugs such as semaglutide and tirzepatide, for treating diabetes and obesity.
  • Expedite the Entry of New Drugs:  Drugs like donanemab (which slows cognitive decline in early Alzheimer’s patients)  as well as for cancer therapies like Tarlatamab (lung cancers) and Tovorafenib (pediatric brain tumour) can now enter into the Indian market.
  • Early Access to Cutting-Edge Therapies: The waiver will ensure that drugs which have undergone rigorous regulatory testing already in other countries are now available for the Indian population, especially drugs meant for rare diseases, where trials can take longer to recruit participants itself. 
  • Not a Blanket Waiver: There is a committee to look into the efficiency of the Drug on the Indian population transparently, Thus deliberately delaying a drug’s use for local trials will be unethical. 

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