Islamabad - The Drug Registration Board Tuesday approved the import of a recently introduced drug for the treatment of Hepatitis C infection on highly subsidised rates. A tablet of the newly invented drug available in the United States at $1,000 will be available expectedly at $20 in Pakistan.
The 245th meeting of Drug Registration Board was held on 29-30 September in committee room of Ministry of National Health Regulation and Coordination under Chairmanship of Ghulam Rasool Dutani, Director (Pharmaceutical Evaluation & Registration).
In two days deliberations, the Board discussed various cases pertaining to registration and quality control of pharmaceutical and medical devices by the local manufacturers as well as imported products. During the meeting, registration for newly licensed manufacturing units/ additional sections and already licensed manufacturing units were discussed.
The Board approved around 200 products for registration. It also approved new drug application of Sofosbuvir Tablet, which is the recently introduced therapy for the treatment of Hepatitis C infection. Registration of this product is a breakthrough in the treatment of this deadly disease. “It is a good news for hepatitis C patients as the cost of the treatment would be too less besides the patients would not have to go through the pain of injections,” remarked Chairman Drug Licencing Board and Director Quality Assurance at Drap A. Q. Javed.
“The innovator company based in USA as a goodwill gesture and on humanitarian grounds will provide the drug only to Pakistan and Egypt on much cheaper rates as prevalence of hepatitis C in both the countries so high,” he said. “If six months treatment cost $180,000 in USA, the treatment will cost $3600 in Pakistan. It will also take away the pain of injections, as having a tablet is more convenient than going through a course of injections for six months,” he added.
According to reports, over 7 per cent population in Pakistan is infected with hepatitis C and the ministry was receiving requests from health practitioner to take measures to make available the drug in the local market.
“To avoid any smuggling or ill-practices, the colour of the drug would be kept different in Pakistan and in the US,” the officials added. The Registration Board also considered cases of substandard drugs and suspended registrations of two products after giving personal hearing to these manufacturers and issued final notices to six manufacturers for being involved in the manufacturing of substandard drugs.
The Board gave directions to recall all such batches from the market.
The meeting was also attended by experts from medical and pharmaceutical fields, including Lt General (Retd) Karamat Ahmed Karamat, Prof. Dr Muzammil Hasan Najmi, Brig. Dr Aslam Khan, Directors Drug Testing Laboratories from Punjab, Sind, Khyber Pakhtunkhwa and Baluchistan and Directors from Drug Regulatory Authority of Pakistan. Representatives from Pakistan Pharmaceutical Manufacturers Association, Pharma Bureau and Pakistan Chemist & Druggist Association also attended the meeting as observer.