Drug board expedites process for registration of new therapy for Hepatitis C

Source: The News

24 July 2014


Paying heed to the recommendations of the Technical Advisory Group (TAG) on Viral Hepatitis, the Drug Registration Board Wednesday unanimously agreed that Sofosbuvir tablet, the new therapy approved by the US FDA for treatment of hepatitis C, should be registered on priority basis if other regulatory requirements are met.




The consensus emerged at the 244th meeting of the Drug Registration Board here Wednesday. The two-day meeting, which was held at the Ministry of National Health Services, Regulations and Coordination, had the director of Pharmaceutical Evaluation and Registration in the chair. Dr. Huma Qureshi, executive director of Pakistan Medical Research Council and secretary of TAG on Viral Hepatitis also attended the meeting on special invitation.



She informed the Registration Board that in Pakistan, prevalence of Hepatitis C is 5 per cent, which is the second highest in the world after Egypt. She shared that in its recent meeting, TAG had in-depth discussion on the new therapy and it strongly recommended that the new treatment be made available to Hepatitis C patients in Pakistan on an urgent basis. Having considered the new drug application of Sofosbuvir tablet, the Drug Registration Board evaluated all registration dossiers and informed applicants about the shortcomings in the applications to expedite the process.



The two-day meeting featured discussions on various cases pertaining to registration and quality control of pharmaceutical, biological drugs and medical devices for local manufacturers and imported products. Registration for newly licensed manufacturing units and additional sections were also discussed. The Board also discussed cases of biological drugs for local manufacturing. It permitted applicants to manufacture pilot batches for conducting further bio-similarity studies. Cases of sub-standard drugs were also considered and registrations of 4 products were suspended. Final notices were issued to six manufacturers for sub-standard drugs.



The meeting was attended by experts from medical and pharmaceutical fields including Lieutenant General (r) Karamat Ahmed Karamat, Prof. Dr. Muzammil Hasan Najmi, Brigadier Dr. Aslam Khan, directors of drug testing laboratories from Punjab, Sindh, Khyber Pakhtoonkhwa and Baluchistan, and directors from the Drug Regulatory Authority of Pakistan.



Representatives of Pakistan Pharmaceutical Manufacturers Association, Pharma Bureau, and Pakistan Chemists and Druggists Association attended the meeting as observers.




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