The Case of ‘Ja’alee’ (spurious) Drugs – Licensing & Registration- Blog Post #283 by Asrar Qureshi

Dear Colleagues!  This is Pharma Veterans Blog Post #283. Pharma Veterans shares the wealth of knowledge and wisdom of Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. If you wish to share your stories, ideas and thoughts, please email to asrar@asrarqureshi.com for publishing your contributions here.

Continued from Previous……

Before the formation of DRAP, the regulatory body was Drug Control Organization. It was part of the Ministry of Health and was entirely funded by the government.

Drug Regulatory Authority Pakistan (DRAP) was established in 2012 enacted under DRAP ACT, 2012. The Authority is mandated for effective coordination and enforcement of the Drugs Act, 1976 to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods in the country.

The authorities, as you know, are autonomous bodies and are required to generate their own funds. Soon after its formation, DRAP revised and increased manifold all fees related to licensing and registration.

DRAP has its own permanent staff for the mandated jobs. It also gets services of relevant experts for specific activities. Two such cases are Central Licensing Board (CLB) and Drug Registration Board (DRB), which are composed of DRAP staff, independent technical experts, and representatives of drugs related trade bodies.

Central Licensing Board, CLB handles the approval of manufacturing units in Pakistan and abroad. CLB makes panels for inspection, reviews their reports and decides whether to accept or not applications from units. CLB also reviews and approves amendments, additions, and changes in the manufacturing sites. CLB also approves manufacturing sites abroad, if finished products have to be imported from that site.

CLB comprises of DRAP staff, independent technical experts, and ex-officio members from other government departments and representatives of trade bodies. It holds its meetings periodically to consider the agenda prepared by the support staff. CLB has a list of mandated jobs which may be summarized as follows:

·      Approval of site for establishment of Pharma manufacturing unit

·      Approval of layout for Pharma manufacturing unit

·      Approval of manufacturing facility after its establishment

·      Grant of Drug Manufacturing License

·      Grant of GMP (Good Manufacturing Practices) Certificate

·      Approval of additional sections

·      Approval of changes in the manufacturing unit

·      Renewal of Drug Manufacturing License and GMP Certificate

As of November 2019, the number of valid licenses holding pharma manufacturing units is 621.

Other major arm of DRAP is Drug Registration Board. DRB is mandated to review and register drugs on the basis of submitted dossiers. DRB comprises of DRAP staff, technical experts, ex-officio members and representatives of trade bodies. DRB also meets periodically and considers the agenda prepared by the support staff for the meeting.

DRB activities may be summarized as follows.

·      Approval of drug registrations

·      Renewal of drug registrations (normally after every five years)

·      Approval of formulation changes

·      Transfer of drug registrations

·      Approval of Toll manufacturing

·      Drug recalls

Drug registration activity has been inconsistent in the sense that periodic meetings are not held on regular basis. The dossiers pile up and the agenda of DRB expands to several hundred pages. How can so much be covered in two- or three-days meeting, is beyond comprehension. But several hundred pages agenda is religiously presented in every DRB meeting.

The number of registered pharmaceutical drugs in Pakistan is now close to 100,000. This number was debated for some time but lately this discussion has stopped, and the registrations are going on unabated. The recent shift to CTD format dossier has put brakes on the speed but it may be transient.

There is a pricing section still under MoH which fixes the prices of drugs after registration approval has been granted by the DRB.

In May 2014, DRAP issued rules for Alternative Medicines and Health Products through SRO 412(1)2014. Thus, initiated the Enlistment of nutraceutical products, nutritional supplements, herbal drugs. Prior to this, the entire business of so-called alternative medicines was completely uncontrolled. Even after Enlistment, pricing is still not controlled in this segment. The manufacturers of Alternative Medicines can charge whatever they wish, and apparently they are doing so.

Some Potential Problem Areas

o   DRAP as regulator has two main functions; regulate current business to conform to prescribed standards and keep pushing for the upgradation of facilities and work standards. On both counts, DRAP effectiveness falls short of expectation, major reasons being lack of resources and lack of will.

o   DRAP is continuously improving its processes. It has been supported by international agencies by way of sponsored trainings and consultancy. However, it is still quite a long way to go.

o   The process of establishing a Pharma manufacturing unit is regulated from the fist to the last step, and no action can be done without the explicit approval of the regulator. Even after this rigorous looking procedure, the Pharma units vary widely in their location, layout, equipment, manufacturing, quality testing, capability and staffing.

o   Drug Manufacturing License is valid for five years. Next plant inspection will be done after five years when the renewal becomes due. In between, GMP inspection falls due, but there are long delays in this also.

o   Provincial structure of Drug regulation is a mix of federal and provincial staff. The overall working coordination is not as it may be desired.

o   A Pharma manufacturing unit can get unlimited number of drug registrations for the approved sections. For example, if a unit has tablet manufacturing section, it can apply and get any number of tablet-form registrations. No questions will be raised about capacity. Questions are raised about capability if a special form is to be manufactured.

o   The agenda of every CLB and DRB meeting is so huge that it cannot be discussed in the allocated time. In the interest of expediting the matters, some matters are likely to be overlooked.

o   DRAP does not have adequate number of staff for evaluation of technical dossiers. It is a cause for delay and piling up and some missing out as well.

Potential problem areas are avenues where a non-conformance to standards is likely to happen.

Home industry gets preferential treatment in all countries; from the most developed to the least developed countries. Same is true for DRAP attitude at home and abroad. A wider gap creates disparity in standards.

An anecdote would elaborate this point further. In 2005, I visited Ethiopia and submitted documents for inspection of Pakistan plant by their regulatory authority DACA (Drug Administration and Control Authority) located in the capital Addis Ababa. Some other Pharma companies from Pakistan were also pursuing the same.

I happened to know the owner of a Pharma manufacturing company in Addis Ababa for couple of years. I called him and paid a visit to his plant. During conversation, I asked him about DACA regulations for the local manufacturers. He told me that they were largely unregulated and DACA was then trying to bring in some control.

Six months later, three young inspectors from DACA came to Pakistan. They visited nine plants in Karachi and four in Lahore. They raised a large number of observations and were not satisfied with any unit here. You can see the great disparity between the attitude at home and abroad.

Continued……