The Union health ministry has given permission to multinational drug company Novartis to import and market its Cushing's disease drug, Pasireotide, without conducting any local clinical trial on Indian population.
Senior officials said that the Apex Committee, constituted by the Union health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country, in its 18th meeting held on November 25 agreed to the proposal of Novartis to market the drug without any local trial in the country.
As per the Union health ministry's new directive, which was based on the recommendation of Prof. Ranjit Roy Chaudhury committee report, “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”.
Earlier, the Technical Committee, another high-level committee constituted by the ministry on the directive of the Supreme Court for monitoring clinical trials, in its 11th meeting had examined the proposal of Novartis for waiver of local clinical trial for Pasireotide. After detailed deliberations, the Technical Committee had recommended that waiver of local clinical trial may be granted subject to the condition that drug should be manufactured in the country along with PMS study as recommended by the then NDAC.
Not satisfied with the Technical Committee's recommendation, Novartis India made a representation to the DCGI, wherein the firm mentioned that Pasireotide has been granted 'Orphan Drug' status by major regulators world over including the US FDA and EMA and it is indicated primarily for use in patients of Cushing's disease which fails both surgical intervention as well as radiation therapy. The overall incidence of Cushing's disease is low. Considering factors like healthcare access, diagnostic rates and patients willing to undergo surgery, etc., the ultimate number of patients who would qualify for use of Pasireotide would be very small, Novartis argued.
Based on the preliminary market research conducted in India, Novartis anticipates that only around 1500 patients per year would be eligible for treatment with Pasireotide Disparate. Considering this, it may not be practically feasible to set up a manufacturing site in India for this product where the overall expected patient population which would require the drug is abysmally low, it said.
After re-examining the issue in view of Novartis' representation to the DCGI, the Technical Committee opined that “as the number of patients in India would be very small i.e., around 1500 per year, as informed by the firm, this orphan drug (Pasireotide) used in Cushing's' disease may be allowed to be imported and marketed. As far as its manufacturing in India is concerned, it shall be left to the applicant firm”.
The Apex Committee deliberated the issue in its meeting on November 25 and agreed with the recommendations of the Technical Committee.