Karachi: The National Assembly’s Standing Committee on National Health Services has offered to act as a mediator among drug manufacturers, the health ministry, and Drug Regulatory Authority of Pakistan (DRAP) so that issues could be resolved on a priority regarding manufacturing and availability of essential medicines in the market to avoid shortage of mandatory drugs.
The offer to resolve issues concerning manufacturers of medicines in the country came as the concerned National Assembly’s Standing Committee met here the other day in Islamabad at the offices of Ministry of National Health Services, Regulation, and Coordination. 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 in the country attended the meeting.
Chairman of Standing Committee MNA Khalid Hussain Magsi offered on behalf of his select committee mediation among three key stakeholders concerning Pharmaceutical industry and medicines’ market of Pakistan. After listening to grievances of representatives of the country’s drug manufacturers, chairman of the standing committee proposed an exclusive meeting among the representatives of federal health ministry, DRAP, and Pakistan Pharmaceutical Manufacturers’ Association (PPMA) to sort out issues of Pharma industry on an urgent basis to safeguard legitimate interests of the industry and that of ailing citizenry of the country.
The PPMA Central Chairman Dr Sheikh Kaiser Waheed said in a statement issued here 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 and for 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 illnesses and life threatening situations. He said that under normal circumstances, such opioid medicines were available in highly affordable rates in market.
He said that in certain such instances of opioid drugs only one or two manufacturers had been left in the country, which have been 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 interests of both manufacturers and consumers of medicines without causing undue burden or exploitation of any of the two main concerned stakeholders.
He said that decisions were mostly taken by DRAP without any scientific, rationale thinking, and application of judicious mind compromising interests 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 erring or corrupt officials of the authority working against the public interests.
State Minister for Health while speaking on the occasion that her ministry was fully committed to support and get resolved long pending issues of Pharma industry of the country.
The PPMA chairman, meanwhile, said that one recent such ill-advised decision was intimation by a DRAP official to the Customs’ Authorities to restrict import into the country of raw material and other drug products, which didn’t come under the definition of registered medicines or their raw material 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 the recent setting up of 13 directorates of DRAP had only further hampered decision making by the drug sector regulator causing issues of Pharma industry only to get aggravated.
He said that another main issue for which help of the National Assembly’s standing committee was sought was non-implementation by DRAP and other concerned authorities of health and Pharma sectors on the directives given by the State minister earlier in February this year when she met central office-bearers of PPMA.
The directives of the State minister, which has yet to be implemented included: Starting of one-window operations by DRAP to facilitate drug manufacturers, delegation of more powers to chairman of drug Registration board, decreasing to 05 years minimum experience required for acquiring license for drug manufacturing, 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,” said the directives of State minister to DRAP issued on February 10, 2016, which are yet to be implemented.