The country’s drug controller is planning to waive local clinical trial of drugs meant to treat certain type of cancer, AIDS, hepatitis and rare blood disorders if the drugs are cleared in “well-regulated” countries like the US, Australia, Canada, Europe and Japan.
This will lead to quick availability of several drugs needed to cure life-threatening ailments and rare diseases, said Drug Controller General of India (DCGI) GN Singh, adding a proposal in this regard has been forwarded to the Health Ministry for its approval.
However, such drugs will be subject to strict post-marketing surveillance for four to six years to look into their safety and efficacy.
The decision is in keeping with the recommendation of Prof Ranjit Roy Chaudhury committee report, which said, “The waiver of clinical trial on Indian population for approval of new drugs, which have already been approved outside India, can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy”.
Singh said that the Drug Technical Advisory Board (DTAB), the Government’s highest decision-making body in respect of drug clearance, at its last meeting agreed that clinical trials for a certain segment of drugs will now be done “only if required”. The Drug and Cosmetic Act, so far, does not allow any drug to enter domestic markets for sale unless these have cleared three phases of clinical trials pre-approval.
“As phase III clinical trials on a drug is a long process, usually taking up around two years, we don’t want the patients to suffer,” said the drug controller, adding that the waiver would also require drug sponsors “to agree to implement a four-year post-marketing surveillance plan, which would need to be approved by us”.
“This is to ensure the drug quality and its efficacy,” added Singh.
The drug controller said that since the clinical trials are undertaken in developed countries under strict vigilance and safety, there is no question of raising safety issues in such drugs.
Though earlier also the Government had been approving drugs falling in such categories, the issue was relooked again after Parliamentary Standing Committee in its 59th report had raised concerns on approval of certain new drugs in the country without local clinical trials.
In its proposal to the health Ministry, the DCGI observes that conducting local clinical trial with new drugs indicated for serious/life threatening diseases like cancer and AIDS which are already approved in other country will delay its introduction as well as increase the cost for the patients in case no satisfactory alternative therapy exists.
As per Chennai-based Foundation for Research on Rare Diseases and Disorders, it is generally accepted that a disease having fewer than 100 patients per 100,000 population is described as rare disease and fewer than 2 patients per 100,000 is described as ultra rare disease. Ultra rare diseases are rarest of rare diseases. Rare and ultra rare diseases are sometimes referred to as orphan and ultra orphan diseases, respectively.
There around 72 crore patients in India suffering from rare diseases with most common being Haemophilia, Thalassemia, Sickle-cell Anaemia and Primary Immuno Deficiency in children, auto-immune diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, Cystic Fibrosis, Hemangiomas and certain forms of muscular dystrophies.
