Pakistan is contemplating a comprehensive revamp of its drug regulatory system in the country in tune to global standards, and to bring traditional medicines under the ambit of the regulatory environment.
According to informed industry sources from Pakistan, plans are to set up a Drug Regulatory Agency (DRA), almost similar to India's proposed National Drug Authority (NDA) in the lines of the functioning of the US FDA. A consultant from US with expertise in the regulatory environment of US FDA has been appointed by the Pakistan government, and the proposals are likely to be submitted within one or two months.
Further, Pakistan is in the process of bringing all non-allopathic medicine systems under the regulatory ambit under the provisions of the Drugs Act 1976. The National Assembly Standing Committee on Health had unanimously approved the Tibb-i-Unani Ayurvedic, homeopathic, herbal and non-allopathic medicine bill, 2005 during May, this year. Later the bill was presented in the Parliament.
The bill is to regulate the manufacturers, import, export and sale of all systems of medicines in consultation with stakeholders, including the provincial governments and relevant departments. It envisages constitution of a board comprising representatives of provincial governments and experts from relevant fields of medicine, besides establishment of laboratories for testing and analysing traditional medicines to ensure its quality. The bill also has provisions to appoint drug inspectors to inspect manufacturing, storage and sale of traditional medicines. The bill is still pending for approval from the cabinet division and the parliament for enacting as an act, said sources.
They said traditional medicines have huge popularity and are widely used by the public. Traditional Ayurvedic practitioners and hakims of Unani medicine are in plenty, though the authorities lack statistics on the market size for traditional medicines. Pakistan also has five to six large-scale traditional drug manufacturers with good sales. A strong lobby of traditional medicine manufacturers and practitioners are working against enactment of the medicine bill, to escape from the regulatory environment, said sources.