The Pharma Bureau has urged the government to immediately form an independent central drug regulatory authority (DRA), adopting the refined model employed in other nations, to oversee the pharmaceutical industry.
In a statement issued on Saturday, the representative body of the multinational pharmaceutical companies operating in Pakistan, associated with the Overseas Investors Chamber of Commerce, said an independent DRA is urgently needed to ensure patients’ welfare and safety and to rebuild confidence of the public in the pharmaceutical industry.
“Pakistan is lacking a central regulating authority since the devolution of the health ministry post-18th Amendment, which is a major concern for the industry and the Pharma Bureau in unison with the PPMA has been highlighting this to the government since 2010, the spokesman for the Pharma Bureau said in the statement.
“This matter is now taking on greater urgency, especially in light of current tragic events.”
Expressing extreme concern over the current tragedy unfolding at the PIC in Lahore, the spokesman said that even though none of the Pharma Bureau members’ products are responsible for the deaths, but the body has proactively been in touch with the authorities to assist in the ongoing investigation.
The spokesman said that Pharma Bureau’s members take extreme care about patients’ safety and welfare and its reputation in Pakistan is built around the same exacting high quality standards these multinational concerns employ in other countries to produce quality medicines.
“All our members follow worldwide Good Manufacturing Practices guidelines, which include full quality certification of raw material and other inputs in the manufacturing of medicines, Quality standard operating procedures for every step in the manufacturing and selling process, strict testing of medicines post-production and zero-tolerance of any deviation from standards,” the spokesman said.
Pharma Bureau also strictly monitors any adverse reports received about the medicines sold in Pakistan including international coordination with laboratories to verify and report on any findings.
The spokesman advised the public not to reach extreme conclusions based on events, which are still not conclusive and the investigation of which is still in its early stages. The issues at hand are complex and early conclusions cannot be drawn without full investigation of facts.
However, the spokesman urged the relevant authorities to expedite the investigation so that rectification steps can be put in place immediately to ensure that this kind of event does not recur in the future.
