The National Assembly's Standing Committee on National Health Services (NHS) has offered to mediate between drug manufacturers and the health ministry and Drug Regulatory Authority of Pakistan (DRAP)to help sort out their differences that impeded manufacturing and availability of essential medicines in the market and caused shortage of mandatory drugs.
The offer to resolve the controversies relating to manufacturers of medicines in the country was made at the National Assembly's Standing Committee on the NHS that met in Islamabad, the other day, at the Ministry of NHS, Regulation, and Co-ordination. Minister of State for National Health Services Saira Afzal Tarar, senior health officials, members of the standing committee, representatives of drug manufacturers, managers of all vertical health programmes, attended the meeting.
After listening to the grievances of the representatives of the country's drug manufacturers, Chairman of the Standing Committee Khalid Hussain Magsi, MNA, proposed an exclusive meeting of the representatives of federal health ministry and the DRAP with the Pakistan Pharmaceutical Manufacturers' Association (PPMA) to sort out controversial issues of Pharma industry on an urgent basis with a view to safeguard legitimate interests of the industry and the ailing citizenry of the country. The PPMA Central Chairman Dr Sheikh Kaiser Waheed said in a statement on Monday that one of the main issues raised by representatives of local drug manufacturers at the meeting was the acute shortage of medicines containing narcotic content, which was otherwise used to manage cases of acute pain alongside treating cancer patients.
He said that undue restrictions and ill-advised regulations had caused unnecessary shortage of such opioid drugs in the local market to the utter disadvantage of patients suffering from serious illness and life threatening condition. He said that under normal circumstances, such opioid medicines were available at highly affordable rates in the market.
He said that due to uncertain market situation, only one or two opiod manufacturers were left in the country and they were producing such drugs despite highly non-conducive control regime but their production could not meet high demand of such medicines.
Dr Waheed said that representatives of PPMA urged participants of the meeting to ensure deregulation of DRAP to make it an autonomous regulatory authority of the Pharma sector and make it free from clutches of bureaucracy so that the DRAP could take decision in the best interest of both manufacturers and consumers of medicines without causing undue burden or exploitation of any of the two main stakeholders.
He said that decisions were mostly taken by DRAP without rationale thinking by compromising the interest of the ailing citizens. The PPMA chairman said that no appellate authority was available to challenge irrational and unwise decisions of the DRAP. He also lamented that chief executive officer of DRAP lacked any authority to take action against corrupt officials of the authority working against the public interest.
The PPMA chairman said that one recent ill-advised decision was intimation by a DRAP official to the Customs' authorities to restrict import of raw material and other drug products, which didn't come under the definition of registered medicines owing to which import and manufacturing in the country of alternative medicines, formula milk for infants, and other materials related to cosmetic treatments had become highly endangered. He said that recent establishment of 13 directorates of DRAP had further hampered decision-making by the drug sector regulator making Pharma industry problems from bad to worse.
He said that another main issue for which they sought help of the National Assembly's standing committee was non-implementation by DRAP and other concerned authorities of the directives of the State minister she gave in February this year a meeting with the PPMA officials. He said that her directives awaiting implementation included: Starting of one-window operations by DRAP to facilitate drug manufacturers, delegation of more powers to chairman of Drug Registration Board, 05 years minimum experience for drug manufacturing license, resolution of pending cases of drug registration, and introduction of system of pharmacist internees in Pharma industry for overcoming its HR shortage.
"These matters need to be given importance for improving the exports of medicines from the country. Implementing these steps will result in the availability of safe, efficacious, and cost-effective drugs to the patients and will strengthen the pharmaceutical industry in Pakistan," according to the directives of the State minister to DRAP issued on February 10, 2016, which were yet to be implemented. State Minister for Health said that her ministry was fully committed to support and sort out the longstanding issues of Pharma industry.