LAHORE: The Lahore Chamber of Commerce & Industry has demanded of the Drug Regulatory Authority of Pakistan (DRAP) to form a liaison committee as any further delay will destroy the pharmaceutical industry.
The demand was raised by the LCCI President Malik Tahir Javaid while talking to the Chairman Drug Regulatory Authority of Pakistan (DRAP) Dr. Sheikh Akhtar Hussain at the Lahore Chamber of Commerce & Industry. The LCCI Senior Vice President Khawaja Khawar Rashid, Mian Misbah ur Rehman, Ijaz A. Mumtaz, Kh. Shahzeb Akram, Naeem Hanif and others were also present.
Malik Tahir Javaid said that a liaison committee comprising members from LCCI and DRAP would help deal with issues pertaining to health and pharma sector.
Chairman DRAP welcomed the proposal and also said that operations and regulations of DRAP are being restructured and transformed on modern scientific basis.
The LCCI President Malik Tahir Javaid drew the attention of DRAP Chairman towards increase in dollar rate, late issuance of final registration letter and form six & seven to the importers. He said that there is 15% increase in exchange rate of dollar which has made the production of such medicines unviable that are made of imported raw material. DRAP must take necessary step to give instant relief to the industry.
Malik Tahir Javaid said that DRAP issued Medical Device Rules 2015 which have now been replaced with Medical Device Rules 2017. These are much simplified and less cumbersome than the previous rules, however, there are still a number of practical difficulties for businesses dealing only in medical devices with no links to the pharmaceutical sector.
He said that majority of our concerned members feel that DRAP Act 2012 and SRO 412 have many ambiguities which should be addressed on priority basis. Furthermore, DRAP needs to ensure clarity in implementations of rules and procedures with regional offices as well. He said that there are still some bottlenecks in the registration of veterinary medicines/vaccines. Our members have to wait long and make a lot of efforts for getting the final registration letters issued.
The LCCI president said that the officials of DRAP raise objections in piecemeal fashion on all the applications submitted by such companies that deal in nutritional products. It causes undue delays and waste of efforts. He said that it is requested that all the objections may be made by the DRAP at one time so that the concerned companies are able to remove these objections simultaneously.
Malik Tahir Javaid said that when the applications for enlistment of companies are submitted after completing all the formalities even then the Form 6 is issued after a long delay. There should be stipulated timeframe given by DRAP in this connection. He also suggested that a liaison committee comprising members from LCCI and DRAP should be formed to deal with issues pertaining to health sector.
