Pakistan Pharmaceutical Manufacturers Association (PPMA) on Wednesday expressed complete support to the government's initiative for establishing Drug Regulatory Agency Pakistan (DRAP). PPMA Chairman Muhammad Asad said that establishment of DRAP would help achieve the objectives of drug regulation in the country for the benefit of the consumers and the industry.
He 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 in clause 3(3), the name of the concerned department needed 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" needed to be further established. Regarding the Clause 9(j), he said the process needed to be defined for the selection of experts in the policy board from public and private sector. He also said that clause 23 of the Ordinance should be amended so that the federal government could make rules on the recommendation of the DRAP.
Under clause 24 of the Ordinance, DRAP should only be able to make regulations, and not rules, he added. Regarding clause 30, he said 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, proposing that a comprehensive training programme for the development of drug inspectors should be instituted.
He said that some private businesses were lobbying for alternate regulatory frameworks to achieve business gains but these proposals had inherent flaws, which would further complicate the drug regulatory needs of the country, eventually affecting the customers and the industry.-PR