Regulator accuses drug makers of needless litigation

ISLAMABAD: The Drugs Regulatory Authority of Pakistan (DRAP) has blamed the manufacturers and importers of medicines for dragging the authority into different courts on the issue of drug pricing and claimed that only the Islamabad High Court (IHC) has jurisdiction to decide such matters under the Drugs Act, 1976. In a report submitted by Deputy Attorney General Sajid Ilyas Bhatti on behalf of DRAP in a pending suo motu case with the Supreme Court on the price increase of drugs, the authority has requested the apex court to pass a final judgment by holding that only the IHC and not any other civil or high court has the jurisdiction to decide cases relating to the prices of medicines. The subject of licensing, registration, import, export, quality control and fixation of prices of different drugs comes under the ambit of the DRAP which is supervised by the Ministry of National Health Services Regulations and Coordination, having headquarters in Islamabad. Even the meetings with the pharmaceutical manufacturers or importers are convened in Islamabad whereas SROs or notifications are also issued from the federal capital, the report argued. Therefore, only the IHC has the jurisdiction in such matters and no other civil court or high court can assume the jurisdiction, the DRAP highlighted. Pendency of at least 17 litigations by different pharmaceutical companies before different courts may cause conflicting views or judgments and it is in the interest of justice that the question about the jurisdiction be decided by the Supreme Court once for all, according to the report. Despite a clear law, the authority argued, the manufacturers and importers filed civil suits before the Sindh High Court (SHC), Lahore High Court (LHC) or civil judge Lahore in their plenary civil jurisdiction which was not permissible under the law and by concealing the material facts they had managed to obtain interim injunctive orders in their favour. Under section 12 of the Drugs Act, 1976, the federal government which is empowered to fix maximum retail prices of drugs has already approved the drugs pricing committee of DRAP to fix and review maximum retail prices of drugs subject to approval by the federal government. Similarly Section 39 of the drugs act bars all civil courts except a drug court to have jurisdiction to entertain cases relating to the drugs. After the devolution of the health ministry in June 2011 through the 18th Amendment, the Drug Control Organisation was placed under the administrative control of the Cabinet Division till the formation of the DRAP. The authority was later set up when former president Asif Ali Zardari promulgated the DRAP Ordinance, 2012, on Feb 17 for regulations of pharmaceutical companies after the Supreme Court took suo motu notice of the deaths of over 100 heart patients under treatment at the Punjab Institute of Cardiology (PIC) Lahore either because of spurious drugs or wrong prescription of blood thinning and lipid lowering medicines in January, 2012. The drug pricing committee in its meetings on June 26, 2012 and in July 2012, fixed prices of 92 drugs considering all facts, justifications and evidences produced by the pharmaceutical companies and prices of competitors in the market and keeping in view the interest of poor people. But some manufacturers managed to obtain restraining orders from the LHC after raising the prices of the drugs exorbitantly by 46 to 421 per cent on the pretext that the prices of those drugs were de-controlled and were not notified in the official gazette. The report highlighted that all the manufacturers who earlier filed petitions before the LHC later filed civil suits in the SHC despite the fact that many petitions were still pending before it. In these civil suits the SHC restrained the DRAP from taking adverse action against the companies whose drug prices were fixed by the drug pricing committee and notified in the official gazette of July, 2012, but still they sold these drugs at higher prices.