Govt’s laid back attitude did it: Pharma Bureau

Pharma Bureau, the representative body of multinational pharmaceutical manufacturers, has urged the government immediately set up an autonomous Federal Drug Regulatory Authority (FDRA) to avoid unfortunate incidents like the one that happened in Punjab Institute of Cardiology (PIC), Lahore.
Speaking to a select group of journalists, Pharma Bureau representatives underscored that there was an urgent need of an independent FDRA to ensure patient welfare and safety and to rebuild public confidence in pharmaceutical industry. They underlined that the country had to adopt the similar refined model employed by other nations to oversee and greater control on this very critical industry of Pakistan.
After the passage of 18th Constitutional Amendment, they pointed out, the country was lacking central regulating authority with the devolution of the Federal Ministry of Health which was a major concern of pharmaceutical industry in the country. “Pharma Bureau in unison with the Pakistan Pharmaceutical Manufacturers Association (PPMA) has been highlighting this issue since 2010 but the matter is now taking on greater urgency especially in light of current tragic events,” they added.
They indicated that after the devolution of the Federal Ministry of Health, the government was dealing with this critical subject on ad hoc basis. “On the one hand, the government’s laid back attitude has jeopardised the precious lives. On the other hand, various companies are awaiting government’s approval to introduce new molecules and drugs,” they lamented.
Pharma Bureau representatives pointed out that earlier, the government announced to resolve the FDRA issue by the end of June 2011, but no progress had been witnessed yet. They disclosed that during the last eight month only two meetings were held for drug registration, whereas these meetings were witnessed once a month before devolution. “It can be easily judged that the government has handed over this important responsibility to the Cabinet Division secretary, in addition to her existing duties,” they said.
Expressing their concern over the current tragedy unfolding at PIC, they highlighted that even though none of their members’ products were implicated in deaths but Pharma Bureau had proactively been in touch with authorities to assist in on-going investigation.
They underlined that Pharma Bureau member companies took maximum care about patient safety and welfare and their reputation in Pakistan was built around the same exacting high-quality standards these multinational concerns employ in other countries to produce quality medicines. All their members follow worldwide Good Manufacturing Practices (GMP) guidelines, which included full quality certification of raw materials and other inputs in the manufacturing of medicines, Quality Standard Operating Procedures (QSOP) for every step in the manufacturing and selling process, strict testing of medicines post-production and zero-tolerance of any deviation from standards, they added.
“Pharma Bureau also strictly monitors any adverse reports received about the medicines sold in Pakistan, including international coordination with laboratories to verify and report on any findings,” they said and advised the public not to reach extreme conclusions based on events, which were still not conclusive and the investigation of which was still in its early stages. The issue at hand was complex and early conclusions could not be drawn without full investigation of facts.
They urged the government and relevant authorities to expedite the investigation process so that rectification steps can be put in place immediately to ensure that this kind of event does not recur in the future.