31,534-kg ephedrine quota given to 63 pharmas in 2010: Report

ISLAMABAD - The devolved Ministry of Health allocated a total quota of 31,534-kg ephedrine to 63 different pharmaceutical companies during 2010 whereas M/s Berlex Lab and Danas Pharmaceutical were issued quota of 9,000-kg out of the total one during the same year, reveals the investigations of Federal Investigation Agency (FIA) that were concluded in 2011.More interestingly, the inquiry report shows that the companies accused, M/s Berlex Lab International Multan and Danas Pharmaceutical Islamabad, in ANF (Anti Narcotics Force) drug scandal neither availed any quota of ephedrine nor these had been issued any ephedrine quota prior to 2010. In Pakistan, Alpha Chemicals Lahore is the sole manufacturer of ephedrine and FIA probe shows that M/s Alpha Chemicals issued a total 26,659-kg of ephedrine to 61 pharmaceutical companies during 2010 when the misappropriation of granting out of turn quota of ephedrine to two companies was made. International Narcotics Control Board (INCB) has fixed 22,000-kg as the total annual requirement of ephedrine for Pakistan.The findings of the inquiry show that M/s CCL Pharmaceuticals Lahore is the major user of ephedrine in Pakistan which has been allocated 858.55-kg quota of ephedrine in 2010, 1590 kg in 2009,1440 kg in 2008, 1290 kg in 2007 and 990 kg in 2006. During the year 2009, 16681 kg ephedrine was allocated to 55 different firms.The Agency in its report has written that there were no specific rules and regulations in the ministry of health for quota allocation of controlled drugs. However, there is a general practice that the ministry allocates maximum 500-kg of ephedrine quota to each pharmaceutical company for a year. “There are 37 molecules, which are registered in Pakistan for pharmaceutical manufacturing. The quota of these molecules is allocated by the Ministry of Health. Moreover consumption of only 07 molecules is verified by concerned officials while for the rest of 30 molecules the consumption record submitted by the firms are accepted by ministry of health,” says the inquiry report adding that for precursor chemicals like ephedrine chemists are not bound by law to keep sale record.FIA in its inquiry has said that there was no proper procedure in the ministry of health for pre-evaluation/ cross verification of export requirement /orders. There are no clear legal provisions, which either favour or bar the conversion of quota granted for the export purpose to local manufacturing. The two companies, M/s Berlex had got quota of 6500 kg of ephedrine for an export order for Khaldar Company, Iraq while M/s Danas got 2500 kg quota of ephedrine from the ministry for export purposes to Anwar Alam Yousafzai Company Limited, Afghanistan. But later both the companies requested the ministry that their allocated quotas should be converted for local manufacturing, as their export orders had been cancelled owing to the bad law and order situation in both the countries. It is being suspected that both companies got out of turn quota on fake export orders. The findings of FIA inquiry say that the Director General Health has been using the power granted by the Narcotics Act 1997, SRO or have been delegated by the Registration Board. There are discriminatory powers of Drug Controller to direct Federal Inspector of Drugs to take samples from particular firms at their own will which are evident from the fact that sample has been taken from M/s Berlex but no sampling has been done in the case of Dana Islamabad, further says the inquiry report.

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