Dr. Farnaz Malik, a Ministry of Health official in her presentation An Overview of Quality Assurance System of Drugs in Pakistan gave a general introduction to the drug market in Pakistan, explaining that approximately 45 % of it constituted multinational companies (MNCs). She added that this figure was decreasing steadily with the overall growth rate of the pharmaceutical industry now at about 13 %. Pharmaceutical drugs in Pakistan are controlled both at the federal and provincial level with provinces having a relatively smaller role to play and the federal government regulating the manufacture, import, export, storage, distribution, and pricing of drugs. Licenses are granted to local manufactures based on site verification, layout plan approval, and Good Manufacturing Practices (GMP) inspections. She said the federal government was responsible for conducting regular inspections, reissuing licenses where required, drug testing, and referring illegal activities to the drug courts that deal with infringements of law in the Drugs Act of 1976. The provincial governments are responsible for maintaining local quality control boards, issuing drug sale licenses, and monitoring the storage, transport, and dispensing of drugs within their borders.
Dr. Malik acknowledged that the system still needed improvement, and that the biggest issues were financial ones. She recommended increased numbers of trained staff at testing laboratories and office automation. She added that the government has initiated setting up a drug regulatory authority with increased decision-making and financial autonomy.
Dr. Zafar Iqbal, an Anti-Narcotics Force (ANF) officer in his presentation, A Situational Analysis of Precursors in Pakistan, explained that ‘precursor' is the term for chemicals that act as the main ingredients for drug manufacturing and enhance their potency. He explained the process, stating that the Import Policy Order 2000 - 2001, issued by the federal government administers regulations regarding the import of precursors into Pakistan. The Narcotics Control Division issues NOCs to business entities before the issuance of a certificate by the Central Board of Revenue (CBR). He added that import certificates are never valid for more than a year. Dr. Iqbal explained that since government agencies conducted no background checks on pharmaceutical companies, relatively little is known about how companies utilise their import. He pointed out that many companies had been importing exactly the same volume of certain precursors for several years despite changes in the economic, and political situation of Pakistan. This implies that some organisations may be involved in the manufacture of illegal drugs. He added that some firms actually ignored legal procedures and had instead been meeting their requirements from the open market.
Shedding light on precursor control procedures, he said that firms were required to produce their NOCs at various checkpoints when transporting precursors. The problem, however, is that the certificate only shows the volume permitted by the CBR to pass through, and not the time period for which the certificate is valid. He felt the only way to remedy this was to request firms to produce both their NOCs and CBR certificates. Furthermore, the transport of precursors is supposed to supervised by ANF personnel, but this is seldom done.
Dr. Iqbal explained how friendly relations between customs officials and importers could help firms import more than allowed. He suggested an inter-agency coordination mechanism for policy formulation and review to prevent the misuse of permission to import precursors.
M. Shafiquddin from the Ministry of Health, Government of Pakistan, chaired the session. The discussants were Shafqat Shahzad from SDPI and Akbar Zaidi. There was a debate on whether a political commitment on the government's part would result in a closer scrutiny of the illegal drugs trade. A lively discussion on the link between drug pricing and quality revealed that price deregulation policies of the early 1990s resulted in massive price hikes, forcing the government to adopt a new pricing policy where non-essential drugs remained deregulated, but essential, life-saving drugs were priced based on the pricing of the leading brand. The outcome was that national pharmaceutical companies began raising their prices even when their costs and quality were much lower as compared to the leading brand. When asked to comment on transparency and corruption within the pharmaceutical industry, Dr. Malik said that members of the Chemists and Druggists Association of Pakistan were represented as observers on the federal government's pharmaceutical registration board, as well as the drugs pricing committee. She that the cost of drugs to the consumer had remained constant for the last three years, although there was mounting pressure from the pharmaceutical companies to raise prices. Domestic industry mushroomed, decreasing the market share of the MNCs.
Today, there is a dearth of adequately trained drug inspectors and resources, because the regulatory bodies have been unable to cope with this massive growth
Reported by Ali Shahrukh Pracha
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