ISLAMABAD - The Drugs Registration Board has decided to develop further guidelines for local manufacturers to qualify the minimum regulatory requirements for Hepatitis C drug registration at the earliest by its next meeting in June 2015.

According to the ministry of National Health Services, the board discussed that the submitted data still do not qualify the minimum requirement to establish the quality, safety and efficacy of applied drug product.

The Registration Board in its 248th meeting held on 18th -19th March 2015, decided that local manufacturers/ applicants shall submit laboratory scale scientifically rational stability data for their applications, instead of full scale detailed documents as per international guidelines, so that a more economic but quality drug could be made available in the country.

In this context, some applicants of Sofosbuvir submitted their stability data which was placed before the board in its 249th meeting held on 18th -19th May, 2015. In Pakistan, applications for registration of Sofosbuvir, a new drug used to treat hepatitis C, have been received since last year from various local manufacturers. The application for its brand leader “Sovaldi” a USFDA approved drug product, manufactured by M/s Gilead Sciences USA (the originator) was also applied by M/s Ferozsons Pakistan as their local sole agent.    

All applications were considered in 244th meeting of Registration Board held on 22-23rd July 2014. The Board decided that firms should submit the proper technical and stability data, (which is essential to determine that the product is of quality and will remain safe and effective up to its assigned shelf life), of their applied products as per ICH/ WHO guidelines along with rectification of other deficiencies in their registration application and complete application should be placed before the Board.

Resultantly, M/s Ferozsons Laboratories submitted the technical and stability data conducted by M/s Gilead Sciences, Canada and approved by various regulatory authorities including USFDA, Australian TGA and European Medicine Agency, which was found the most authentic and well establish the drug quality, efficacy and safety. Registration Board in its 245th meeting held on 29th -30th September 2014 approved the product for finished import from M/s Gilead Sciences USA, from its plant in Canada.

The price after both the US and Pakistan governments negotiations with the company was approved as Rs 55,000 per pack of 28 tablets (a regimen for a month), but M/s Ferozesons, local sole agent for M/s Gilead further voluntarily reduced price to around Rs. 32,000 per pack of 28 tablets.

The drug is now available through the distribution outlets of M/s Ferozesons, as per the agreement terms from M/s Gilead USA.

Local pharmaceutical manufacturers provided studies which were not as per ICH/ WHO guidelines or they did not complete the technical documentation necessary for registration under the Drug Act laws and rules, for ensuring quality, efficacy and safety of products to be registered in Pakistan.

Later on, for supporting the local manufacturing as a DRAP policy guideline, the matter was considered as a public health interest and was given a priority.

This nowal drug was introduced in the USA and other European countries after USFDA approval in November 2013 for the treatment of Hepatitis B and C as co-administration and is under the patent protection laws through-out the world. Sovaldi (Sofosbuvir) received the status of Breakthrough Hepatitis C Treatment Drug by United States Food and Drug Authority (FDA).

With sincere efforts of Pakistan’s government, the government of USA advised the drug innovator M/s Gilead to ease its patent rights for poor patients in developing countries like Pakistan. M/s Gilead generously agreed and while reducing its R&D cost margins, it provided drug for developing countries like Pakistan, at almost 50 folds less price.

A single tablet cost in USA around USD 1000; while in Pakistan it is approved at a price of around Rs. 1900, which was further reduced to around Rs.1200 (40%less than the approved price) voluntarily by M/s Ferozesons,the local sole agent in Pakistan of M/s Gilead USA, on further request by Sara Tarar, Minsiter for National Health Services Regulations and Coordination.

To avoid the drug to be smuggled back, the drug and its pack have different color schemes for easy identification, exported to Pakistan and Egypt, from M/s Gilead, USA.

This treatment option has removed the use of PegInterferonalfa injections and become highly cost effective treatment for the suffering patients.

Throughout the country and Pakistanis living abroad having their loved ones suffering from the disease hailed the efforts for making the drug available in Pakistan and at such a low price compared to other parts of the world.