'Strong monitoring needed to ensure pharma industry integrity'

The 'Drug Regulatory Authority' (DRA) should just not only regulate medicines but also the alternative medicines, including homeopathic and all other imported medicines, on which there is currently no control in the country. The Executive Director of Pharma Bureau, Dr Sadia Moazzam, told Business Recorder that the above suggestion is part of the proposals sent by 'Pharma Bureau' to the federal government in the larger national interests of all stakeholders.
These proposals are now part of what the Senate health committee and various other professional bodies are deliberating on, right now. The Pharma Bureau, which is representative body of multinational pharmaceutical companies, has also proposed that the 'DRA' should be staffed with independent experts in the field, who are free from bias and can think independently for the betterment of the country, instead of being stuck in some preconceived ideas.
"We are further proposing that the 'DRA' should regulate not just medicines but alternative medicines, homeopathic and all other imported medicines on which there is currently no control in the country," she added. "The 'DRA' will need to be supported by a robust provincial monitoring structure to ensure that the entire sector is maintaining integrity. This infrastructure needs to include new world class laboratories and research facilities so that products' quality could be tested within the country," she said.
Dr Sadia said that to ensure product integrity, the government has to set up an effectively independent 'DRA' to oversee the entire pharmaceutical sector. "We cannot operate the way we are operating currently, where no progressive work is being undertaken, and an ad hoc status quo is being maintained". She said that an independent and effective 'Drug Regulatory Authority' (DRA), at federal level, with professionals in place having full authority and autonomous status is needed to provide best international standard health care which the citizens deserve.
While appreciating the government's decision to establish a 'Drug Regulatory Authority' under the Federal government, the Pharma Bureau, has also proposed that the 'DRA' should have a strong provincial monitoring set-up to ensure integrity of pharmaceutical manufacturers and the medicines.
The Pharma Bureau had been pointing out that the multinational companies (MNCs) regularly quote very competitive rates in government hospitals. "But our success rates are minimal because the cheapest drug is given preference", she said. She said that the government has to show flexibility when it comes to medicine supply to poor patients. "Why should the poor patients deserve anything less than the affording classes?" she asked.
The Pharma Bureau statement highlights that the absence of uniform standards and proper infrastructure of quality check labs, etc, would lead to proliferation of poor quality drugs. The adherence to Good Manufacturing Practices (GMP) is critical in manufacturing drugs of standard quality, she added.
The post-devolution need for co-ordination with international agencies, World Health Organisation (WHO), etc, could have been compromised. "We would have increased the work undertaken at the Centre by fivefold", she said and asked, "Does the government have the resources to undertake this?"
"The pre-devolution state was definitely not perfect, either, but it was better than what we have currently", she said and added: "As regards drug inspectors, they were functioning previously, and their role will now be even more critical, if we need a greater monitoring effort, to ensure that we are fair to the Pakistani population."