Cardiac stent scandal aftermath: Punjab drug control authority in the offing
LAHORE: In the aftermath of unregistered cardiac stents scam, the Punjab government has started working on establishing a drug regulatory authority at the provincial level, giving the task to the primary and secondary health secretary to materialise the idea as soon as possible.
The step has been taken apparently in the wake of frequently surfacing ‘drug scams’ in Punjab with most of them being related to the quality of medicines – the fresh one was that of unregistered cardiac stents scandal at a public hospital of the provincial capital.
The proposed authority shall be initially called as ‘provincial or Punjab drug control unit’. The final decision regarding the name shall be taken in the coming meetings.
Shortly after seeking a nod from Chief Minister Shahbaz Sharif, the health authorities are all set to write to the federal capital to take over some functions from the Drug Regulatory Authority Pakistan (DRAP) to perform the same at the provincial level.
For this purpose, the due legal process is being adopted by involving the provincial law department as well.
DRAP to continue performing some functions
After the 18th Amendment, the three provinces, namely Punjab, Sindh and Kyber Paktunkhwa, through resolutions some five years ago, had allowed DRAP to perform all the functions, including registration, licensing and pricing of the drugs, at the central level, expressing their inability to do so due to lack of expertise and infrastructure.
Primary & Secondary Health Secretary Ali Jan Khan has confirmed the development, saying the step has been taken to ensure the provision of standard and quality drugs to the patients.
“We are going to withdraw functions from DRAP in phases. In the first phase, the manufacturing licensing and import and export of the drugs from Punjab shall be done at provincial level,” says Mr Jan while talking to Dawn. However, DRAP shall continue performing some other key functions, including pricing and registration, as per previous arrangements, he says.
A lot of work has been done and things are now getting some shape, Mr Jan adds.
Health Additional Secretary (Drugs) Dr Muhammad Suhail, who is also another official behind this move, says that one of the major reasons behind recently surfaced drug scams was failure of DRAP in regulating the drugs effectively.
“There are huge chunks of drugs that are manufactured and supplied in Punjab from other provinces. As Punjab had nothing to do with the licensing, drugs’ registration and quality, it (Punjab) has to face undue criticism when the issues related to the standard of the medicines surface,” Mr Suhail laments.
He further adds that as Punjab’s department has no provision to regulate the drugs (except to the extent of good manufacturing practices), the violators escape punishment.
“Now the Punjab government has decided to perform some functions of DRAP at provincial level by forming an authority.”
To a question about the functions of the proposed authority, Mr Suhail says some of them will continue to be performed by DRAP as the Punjab government wants promotion of the inter-provincial harmony also. Like, he says, the pricing and registration of the drugs shall be done by DRAP. However, the Punjab government shall also play its role in such functions.
“For example, DRAP shall be bound to obtain no objection certificate (NOC) from Punjab regulatory body in pricing or registration issues. For the purpose, terms of references (ToR) shall be finalised.”
According to the official record obtained by the Punjab health department from DRAP, about 350 drug manufacturing units are functioning all over the province.
“In order to materialise the scheme, the initial staff is being recruited in a couple of weeks,” Mr Suhail says and adds that the provincial quality control board, which is to play a key role in this aspect, has already been restructured and revamped by the Punjab government.
“More than 200 drug inspectors have also been recruited who shall be posted at the state-run hospitals to discharge duties at patients’ bedside for the provision of standard medicine.”
The work on storage, distribution and transportation of drugs in a transparent manner to ensure quality and efficacy is in final stages, Mr Suhail says, adding that five drug testing labs in Lahore, Bahawalpur, Multan, Faisalabad and Rawalpindi have also been upgraded to analyse the drugs.
Published in Dawn, February 4th, 2017