Conveying a clear message to vested interests and lobbies that are out to maximize profits at the cost of public interest, Chief of Drug Regulatory Authority in a strongly worded statement said there will be no compromise and the process of reforms will continue. No lobbies or vilification campaigns can stop us from taking on the black sheep in the business said the statement. We are out to safeguard the interest of the public and cannot allow interest groups to wreak havoc with the lives of people by their tactics said Dr. Muhammad Aslam.
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. It is unfortunate that some groups in the trade of medical devices are making attempts to defer and halt the regulation process from time to time so that they can continue and enjoy unregulated system at the risk and cost to patients.
The Government, Ministry of NHS,R&C and the DRAP is committed to enforce Drug Act, 1976 and the DRAP Act, 2012 with full zeal and zest in the larger patient interest and to get rid of illegal trade of drugs and devices from the market. The Authority has taken a number of initiatives to improve its working efficiency and to strictly regulate in order to achieve the objective of ensuring public access to safe, effective and quality drugs and medical devices.
The statement said this recent episode, regarding cardiac stents, as per FIA 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). The DRAP, after detailed deliberations, took a serious notice in its meeting on Thursday 19th January, 2017 based on FIA reports and on initial report of its Lahore Office. In this regard, the Authority constituted a three members technical investigation team with TORs to completely probe in the matter from all angles; regulatory/legal, financial scam/price and unethical and malpractices and to submit investigation report within 10 days alongwith recommending corrective and preventive actions. The DRAP recently promulgated 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 like SRO.957 (I)/2009 dated 5th November, 2009. This regulatory effort is in the patient interest to provide quality assured medical devices. The new medical devices rules are harmonized and at par with international regulations and as per guidelines of World Health Organization.
DRAP has already registered 55 Stents with 25-60 variants (sizes) of each stent since 2010 from world’s renowned manufacturing companies mostly from 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 includes 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 the patients.
Stents are registered after assessing safety, efficacy and quality by the Registration Board consisting of experts from various fields. Even inspection by the DRAP inspection team of the foreign manufacturer is also conducted, in order to verify the 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 etc 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.
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 were thoroughly verified by the DRAP inspection team before allowing registration, for 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, it is submitted 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 to 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 F.I.A investigation, the Authority and the Federal Government would be considering a price control mechanism for these products also.
It may be mentioned that each type of Stent is registered separately as per the 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 could 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 National Health Services, Regulations and Coordination are continuously contesting the illegal drug price increases in the Courts and making all out efforts in this regard.
It is noteworthy for the record that DRAP has in majority registered the stents approved from USFDA, Japan, EU Authorities, etc and only few are from other countries including Turkey, China, etc. but after thorough evaluation and inspection on-site
The statement added with regard to a Karachi based company and misinformation being spread in this regard agitated in a portion of media through so called associations that only for one company one stent with different sizes was registered, which is vehemently denied and it is pertinent to mention that 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 facts were twisted and one reference from 2016 was given while two cases in 2013, were concealed. The allegations therefore are malafide, falsified and baseless and are attempt to disturb the official government business and mislead and distract public and authorities from the illicit and illegal trade.Some companies, whose cases for unauthorized manufacturing of unregistered drugs and illegal manufacturing of sex drugs and violations of registration and licensing conditions, are under process of law; are involved in the media campaign against the Ministry and DRAP for their vested interest and to pressurize the authorities.It is reiterated that patient safety is the first priority of DRAP and there shall be and cannot be any compromise in this regard, concludes the statement.
Ministry and DRAP expect and appreciate media’s positive support and role in strengthening the efforts to eradicate the menace of spurious, fake and falsified drugs and devices from the country. This requires consolidated and coordinated efforts by various authorities including interior ministry, investigation agencies, customs, judiciary, provincial governments, media and public.
