The Pakistan drug control administration is in the process of strictly implementing cGMP norms mandatory for all pharmaceutical units.
Though the Pakistan version of cGMP norms were made mandatory in 1998, the same was not strictly implemented so far. The present drug control administration headed by Dr Farnaz Malik, Drugs Controller of Pakistan, had decided not to issue product registration unless the units have complied with the cGMP norms, with effect from 31st December 2005 as per the Schedule H & Schedule G of the Drugs Act, 1976.
According to informed industry sources, currently many of the manufacturing units in Pakistan, including some of the 22 MNCs operating in the country, lack facilities conforming to the stipulations of the cGMP norms. As per the rule, seven separate sections are mandatory including exclusive areas for manufacturing cephalosporins, antibiotics, general prescription medicines, psychotropic, oncology, hormones, anti-bacterials, TB drugs etc.
The cephalosporins facilities have to be totally an independent unit. Each of the sections requires separate humidity control and air handling units/H-VAC systems etc. In order to adhere to these stipulations, the units will have to invest more than a crore of rupees. Though the multinationals and leading domestic manufacturers have the financial muscle to set up the requisite infrastructure, majority of the domestic units lack adequate finances to set up the facilities.
In order to circumvent the rules and to satisfy drug inspectors, the small units partition the existing facilities and use makeshift fans as AHUs. No financial assistance is available for the modernization process and this is a major worry for the Pakistan pharma industry, already in doldrums.
Since the norms are in place since 1998, the manufacturers associations are not in a position to challenge the norms or appeal the government to re-look the decision. In this scenario, the PPMA has represented to the Health Minister, Drugs Controller and other various provinces heads to have a sympathetic attitude, he elaborated.
The US $ one billion Pakistan pharma industry is controlled by about 50 companies which share 70 per cent of the domestic market. Another 20 companies account for the next 25%, and the remaining 5 per cent is scattered between the remaining units. Pakistan has about 400 registered drug units, including 22 multinational companies, which controls 51% of the domestic market.