In-focus

Business

PPMA backs establishment of Drug Regulatory Agency

Dunya News

PPMA has supported the establishment of Drug Regulatory Agency Pakistan (DRAP).

President Pakistan Pharmaceutical Manufacturers Association Mr. Muhammad Asad has commended the step and has said that establishment of this Agency would help effectively achieve the objectives of drug regulation in the country for the benefit of the consumers and the industry.He further suggested minor changes and clarifications to the proposed DRAP Ordinance and demanded “Member” status for PPMA at the Policy Board of DRAP.Commenting on the DRAP Ordinance, he said that in clause 3(3), the name of the concerned department needs to be mentioned. In clause 3(5), he said, National Institute of Health should be included, appellate laboratory be defined while the term “Surveillance laboratory” needs to be further established. Regarding the Clause 9(j), he said that the process needs to be defined for selection of experts in policy board from public and private sector.He also said that clause 23 of the Ordinance should be amended so that the Federal Government should make rules on the recommendation of the DRAP. He further commented that under clause 24 of the Ordinance DRAP should only be able to make Regulations, and not rules.Regarding clause 30, he added that burden of proof should be on the complainant and on lodging of false allegation; complainant should be liable to punishment.He further commented that under Schedule V of the act, the lock and seal of any factory should not be more than two weeks. The President PPMA also proposed that a comprehensive training programme for the development of drug inspectors should be instituted.Muhammad Asad further added that some private businesses are lobbying for alternate regulatory frameworks to achieve business gains but these alternate proposals have inherent flaws which would further complicate the drug regulatory needs of the country, eventually affecting the customers and the industry.