The Union Health Ministry accorded permission to five more drugs—chronic hepatitis C drug Sofosbuvir, prostrate cancer drug Enzalutamide, cutaneous T-cell lymphoma drug Vorinostat, pulmonary tuberculosis drug Bedaquiline tablets 100mg and Haemophilia drug Rixubis—for importing and marketing in India without local clinical trial on Indian population.

According to sources, the Apex Committee of the health ministry in its meeting held on December 24, 2014 has given its approval for manufacture/import for marketing these drugs in the country without any local clinical trial, citing various reasons.

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”.

The high powered Apex Committee, headed by union health secretary deliberated on  the drug Sofosbuvir, indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC)B in adults.  Concurring with the Technical Committee, the Apex Committee noted that Sofosbuvir is currently the only drug which can be safely used in patients with advanced fibrosis, cirrhosis, interferon ineligible and intolerant and an interferon free therapy with efficacy of 60-80 per cent. After detailed deliberation, the committee recommended for waiver of local clinical trial as per the recommendation of SEC.

The Apex Committee also deliberated on the drug Enzalutamide, which is indicated for the treatment of adult men with metastatic castration resistant prostrate cancer whose disease has progressed on or after Docetaxel therapy.   The committee noted that Enzalutamide 40mg capsule indicated for the treatment of adult men with metastatic castration resistant prostrate cancer whose disease has progressed on or after Docetaxel therapy and there is no similar drug available that act on androgen receptor signaling pathway.

After detailed deliberation, the Committee agreed with the Technical Committee and recommended for waiver of local clinical trial as per recommendation of SEC as no other efficacious drug available in this category.  

On Vorinostat, indicated for the treatment of cutaneous manifestation in patients with cutaneous T-cell lymphoma, the committee noted that the drug is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) which is a serious and life threatening disease for which currently there is no satisfactory therapy.  The drug also qualifies under the criteria of orphan drug as the drug is indicated for a rare disease. Therefore, the Committee recommended for waiver of local clinical trial as well as bioequivalence study in Indian subjects.

Bedaquiline Tablets 100mg, indicated in adults as part of combination therapy of pulmonary tuberculosis due to muiti-drug resistant Mycobacterium tuberculosis, also came up for deliberation during the meeting. The Committee observed that Bedaquiline is approved in US, EU and other major countries. Bedaquiline is indicated for the treatment of pulmonary tuberculosis due to muiti-drug resistant Mycobacterium tuberculosis, (MDRTB) for which presently no effective therapy is available in India.  MDRTB is a serious life threatening condition with high mortality and it is disease of special relevance to Indian Health Scenario. Therefore, the committee recommended waiver of local clinical trial at this stage and the approval of the drug Bedaquiline with restriction that it shall be approved for use under RNTCP framework for conditional access through the PMDT programme for treatment of MDR-TE patients only.

The Apex Committee also deliberated on the drug Recombinant Factor IX concentrate (Rixubis), which is indicated for control and prevention of bleeding episodes in adults with haemophilia B, perioperative management in adults with Hemophilia B, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with Hemophilia B. Rixubis is not indicated for induction of immune tolerance in patients with Haemophilia B.

The Apex Committee agreed with Technical Committee's opinion that the subject drug falls under the status of orphan drug and there is an unmet need in the country for recombinant Factor IX concentrate which is required for the treatment of haemophilic patients, therefore marketing authorisation may be granted to the firm with waiver of local clinical trial in line with the recommendations of SEC.