Reforms in drug regulations unnerve mafias, says DRAP

Islamabad: The chief of the Drug Regulatory Authority of Pakistan (DRAP) Dr. Muhammad Aslam, in a strongly worded statement issued here on Sunday, asserted that the process of reforms will continue, and that no lobbies or vilification campaigns will stop the organisation from taking on the black sheep in the business.

“It is of critical importance that people know the facts regarding the present scam of unregistered stents so that culprits and their sympathizers do not mislead the public,” Dr. Aslam maintained. Explaining, he said, the recent episode regarding cardiac stents, as per FIA’s initial report, has three main facets that include regulatory/legal aspects, financial scam/prices, and commission scandal and unethical practices (using expired, fake, copy, wrong claim of European Union Regulatory Authority approval). After detailed deliberations, DRAP constituted a three-member technical investigation team to probe in the matter from all angles and to submit an investigation report within 10 days alongwith recommendations for corrective and preventive actions.

Dr. Aslam said, DRAP has recently promulgated the Medical Devices Rules 2015. Prior to these, there were no comprehensive rules for medical devices except for some medical devices being declared as drugs to be regulated under the Drugs Act 1976. The new medical devices rules are harmonized and at par with international regulations.

According to the statement, DRAP has already registered 55 stents with 25-60 variants (sizes) of each stent since 2010 from renowned manufacturing companies mostly from the USA, European Union, Japan, etc., and other countries having good quality and Good Manufacturing Practice compliance. Cardiac stents approved by DRAP can cover most of the present requirements, which include old and new advance types, bare metal and drug eluting stents. For any special requirements, DRAP addresses it through urgent processing as soon as the applicant completes and complies with the mandatory requirements for quality, safety and efficacy. This process is in practice and is being applied for various types of therapeutics goods including stents.

“Similarly, for products not available/registered, through special permission, medical institutions can import for patient use. Therefore, in the presence of legal and compliance process, ensuring quality, safety and efficacy of such devices, it requires these devices to be handled appropriately as per law, to avoid risk to patients,” Dr. Aslam says in the statement.

Stents are registered after assessing safety, efficacy and quality by the Registration Board. “Our inspection teams even inspect products of foreign manufacturers in order to verify Good Manufacturing Practices on site. Inspections of only those products are exempted which are already approved by the reference stringent regulatory authorities of USA, Europe, Japan, etc., as specified by the Registration Board. Rest of all countries including Brazil, China, Korea, Malaysia, Turkey, Singapore, India, UAE, Lebanon, Egypt are inspected before grant of registration for products from their countries. Furthermore, Good Distribution Practices for medical devices of importers are also verified by the DRAP Inspectors. Only those devices including stents are registered by DRAP whose safety and efficacy has already been verified, approved and registered by regulatory authority of their country of origin,” Dr. Salam states.

The DRAP chief has pointed out that in case of registration of medical devices from non-exempted countries like China, Turkey, etc., in addition to Chinese or Turkish regulatory authority’s approval, Good Manufacturing Practices of the manufacturers are thoroughly verified by DRAP inspection team before allowing registration of all types of medical devices and drugs. Therefore, only quality manufacturers’ products are accepted after on-site inspection of other countries. “It is pertinent to add that stents are being registered from quality Chinese sources since 2013, well before joining of present CEO, DRAP,” says the statement.

Regarding prices, the statement submits that a comprehensive regulation covering all types of medical devices is under phase-wise implementation. In the first instance, all medical devices shall be brought under regulation and then their prices mechanism will be devised so as to avoid shortage of life-saving medical devices in the market. Across the world, prices of medical devices are not controlled by regulatory authorities but unfortunately due to matters that have surfaced through FIA investigation, DRAP and the federal government will considering a price control mechanism for these products also.

 “Each type of stent is registered separately as per international guidelines and practices whereas each stent is available in different sizes/variants based on patient needs. Product is of one type but these are in different sizes. This is another control so that only those sizes can be imported and sold which are registered. Different sizes of one stent are registered in one application of every company since many years well before the joining of present CEO. This practice is followed even in case of registration of other drugs as well. Worldwide stent and other devices are registered on same analogy. It is added that DRAP has treated all companies and products as per law, policy and rules without discrimination.

DRAP’s Medical Devices Division expeditiously processes the applications. The only applications pending are on part of applicant firms, due to non-submission of mandatory documents for assessing safety, quality and regulatory status of the products whereas some firms have not deposited the required fee or did not comply with other requirement for registration. DRAP registers stent and other devices as soon as applicant fulfills the requirements as per the rules. Similarly, DRAP and Ministry of Health are contesting the illegal drug price increases in the courts and making all out efforts in this regard.

“With regard to misinformation being spread to the effect that only for one company. one stent with different sizes was registered, DRAP vehemently denies the allegation. DRAP is handling registration of stents on merit since 2011 including the referred company whose cardiac stents were registered since 2013, well before joining of the present CEO. The allegations therefore are malafide and are attempt to disturb the official government business and distract public and authorities from the illicit and illegal trade,” Dr. Aslam concludes in the statement.