ISLAMABAD: A bill for creating a Drug Regulatory Authority of Pakistan (DRAP), drafted in the aftermath of the ephedrine scandal, suggests that a specific director oversee the business of controlled and psychotropic drugs.
“It (the bill) is with the parliament and a committee of the National Assembly has already approved it,” federal minister for regulations and services, Dr Firdous Ashiq Awan said.
She hoped the bill would soon become law and lead to better standards and controls in the pharmaceutical industry and prove ‘a win-win situation for all - the industry, the government and the patients’.
She said the policy board of DRAP will frame the regulations for the drug industry. “No pharmaceutical company owner will be considered for the membership of the board,” she added.
When established, the new drug regulatory authority would replace an ordinance that President Asif Ali Zardari promulgated in February this year after more 100 patients died in Punjab of adverse reaction of a drug for heart ailments.
Though the existing Drug Regulatory Agency of Pakistan that the ordinance created had the same objectives, the political storm the ephedrine scandal kicked up forced tightening of the drug control law.
Unlike the Agency which has ‘members’ on its board, the Authority is proposed to have directors for pricing, licensing and quality control, registration of drugs, biological and medical devices, pharmacy services, legal affairs, Information Technology, administration, human resource and development, and, additionally, a director for controlled and psychotropic drugs.
“This (last) position is needed to avert scams, like the one haunting the government now, in future,” said an officer of the Ministry of Regulations and Services.
‘Independent’ drug inspectors are to be appointed to regulate the trade in ‘controlled drugs’.
“We have to come hard on regulation,” the officer said. The International Narcotics Control Board had expressed concern over the free availability of controlled drugs in Pakistan.
New regulatory measures would create more than 1,000 jobs in different fields in the pharmaceutical industry, said another officer.