What important Legal and regulatory changes will affect Pakistan Pharmaceutical Industry in 2021
With the drifting changes in the world due to the pandemic, the year 2020 has turned business, societies & corporations into another dimension. The industries have been forced to take a turn towards a vastly different environment. These changes will persist in the upcoming year as 2021 takes charge. Like the last year, the New Year shall bring new opportunities for growth as well as more friction & uncertainty.
It would be wise to commemorate this year with slightly different perspective. Not to forget, Pakistan’s economy had to suffer a great hit with the rising Pandemic situation in almost every sector. It would be safe to say that the Pharmaceutical industry of Pakistan too suffered a great number of unpredictable losses. To make it more precise, let us look into some of the rising issues with respect to DRAP unforeseeable changes and its impact on the industry, regulatory changes & legal abatements
- Administrative Issues at DRAP and provincial level
While Drug Regulatory Authority of Pakistan (DRAP) is solely responsible for regulating the pharmaceutical industry in Pakistan, there has been many alarms raised during the year over violation of rules and neglecting of critical issues which includes Administrative & provincial level anomalies. Where the world had a keen eye & open mind towards the pandemic, DRAP has shown some significant number of glitches to handle the situation resulting in lack of resources, delay in decisions & absence of official dialogues in order to comprehend with the downfall of market.
The year 2021 needs a better, more active & synchronized system to allow companies to communicate with the DRAP officials freely. With the decreased number of Drug Registration Board meetings held in 2020, the industry is far behind in producing goods without registration. The rising situation of COVID has led to reduce the efficiency and productivity of DRAP, Islamabad that has a drastic impact on company’s day-to-day case submissions.
- Documentation & Supply chain disruption
Application of CTD documentation as made mandatory in March’2019, was a high drift change in local Regulatory Authority. Many companies were unable to implement the newly introduced Form-5F due to lack of knowledge, resources and a clear image set by DRAP. This led the industries to fall back on the registration of newly available molecules. The process has now been made more vigilant and stricter, leaving no breathing space for the new comers in the industry.
Submission of dossiers on CTD format requires a vast list of documents, which at this level is not an easy task for the manufacturers to produce as the major concern for them, is the procurement of API & its related documents.
- Ban on import of raw material from India
The pandemic is causing disruption in the medical supply chain. One area of concern at the beginning of pandemic was the supply of active pharmaceutical ingredients.
Indeed, many Pharmaceutical production and supply capabilities are in India and high demand for some products, coupled with political issues that may affect supply, may put some supply chains at risk. Moving forwards, many manufacturers will be looking to alternative or additional geographies to ensure material availability, and safeguard their supply chain.
However, sourcing products elsewhere or shifting manufacturing operations raises new regulatory complexities.
- PIRIMS software- A challenge for Pharma Industry in Pakistan
With the introduction of PIRIMS (Pakistan Integrated Regulatory Information Management System) earlier this year, many questions were raised as to it’s efficiency & understanding of the software. Companies are still struggling to adopt the working of this system. In addition, the application launched by DRAP in 2017 i.e. DRIS (Drug Regulatory Information System) and all the data contained in it is a question. No clear image of the already existing data in DRAP database has been provided which has left the companies confused if they are to upload all the data from scratch or to upload only the new registrations. This in turn will leave the companies in great distress in coming year, as DRAP has strictly implemented the use of PIRIMS from 2021.
- Cost pressure & pricing reforms
Pricing has been the hot topic since the beginning of the year. Rapid increase in the prices, customers & government pressure to reduce the prices of medicines have made the companies suffer a great amount, considering a huge hit on the market due to COVID. With CPI’2020 implementation in July, many ambiguities have raised related to price increase and its implementation by companies which are yet to be resolved. Many companies are still struggling to get approval due to lack of evidences or continuous changes in DRAP policies and requirements. The coming year for pharma industry with respect to pricing is going to be a challenge and we hope that all such queries and hurdles related to the matter are rectified.
- Inspection delays both at national and international manufacturer facilities
Delays in inspections have been experienced in the year 2020 due to the pandemic situation which has led the companies to suffer from early approval of their DML, GMP (local & Export) along with other licensing approvals requested. Export registrations have become a havoc as inspections mandatory for many foreign countries has been in question and in turn has led companies to suffer from timely approvals of company registration. On the other hand, companies have suffered a tremendous number of delays in product registration procedures due to shut down of MOHs in different countries for export purpose which in turn has led to the decrease of sales and loss of business. Such scenarios had a great impact on 2020 and the same been foreseen in the upcoming year of 2021
- Medical Devices Opportunities & Challenges and beyond
Medical DRAP’s assumption for the last year, allowing companies to import without license now ceases with the end of one-year time. As per the rules, it is Insurance Cover Viagra now mandatory for companies to get themselves registered. Stated by the Medical device division, they would not be issuing any meeting minutes rather will only inform the companies whether their cases are approved/deferred/rejected. Due to COVID, companies inception have been delayed for medical device storage facilities because of which, back in 2020 companies had to deal with a greater loss in importing medical devices like oximeters, nebulizers and ventilators amid to COVID situation. Shortage of such medical devices caused havoc for the public. Coming years shall be a challenge for MD importers as the constant changes being enforced in the industry making it quite difficult and a lengthy procedure for approvals
