The Pakistani pharmaceutical sector is 73 years old, with a humble origin, it has developed into one of the fastest-growing sectors in the country. Over twenty-five, multinational pharmaceutical companies are operating in Pakistan along with over seven hundred and fifty national companies. The pharma industry has witnessed a substantial increase in investment in the last decade and its contribution to Gross Domestic Products has steadily increased, although still much lower than its potential.
How National Companies in Pakistan Offer Quality Pharmaceutical Products
Growing Role of National Companies
There is strong competition between national and multinational players, with the former giving a tough time to the latter more recently. National companies have been investing money and time, every step of the way, from the installation of state-of-the-art manufacturing plants, quality control, effective distribution, and exports. This commitment of national companies has gained them a substantial chunk of the market share. Major MNCs include names like GSK (GlaxoSmithKline), Martin Dow, Abbot Laboratories, Searle, Acto, Barret, and others. The list of national companies is long and includes companies like Nabi Qasim Industries, Don Valley Pharmaceuticals, Sami Pharmaceuticals, Ferozsons Laboratories, etc. Many of the national companies have risen as the best pharmaceutical companies in Pakistan. Overall, the market size of Pakistan’s pharmaceutical sector is estimated to be over 3.2 billion US dollars, growing by over 100 % in the last ten years.
Manufacturing
The Pakistani pharmaceutical sector’s greatest challenge has been and still is the acquisition of API (Active Pharmaceutical Ingredients), which are required for the manufacturing of medicines. Only two such manufacturers exist in the country and over 90% of the API requirement is met through imports. However, Pakistani national pharmaceutical companies have been investing substantial funds in installing and developing manufacturing facilities that comply with both national and international standards. Most of these plants have the latest ISO certifications and follow GMP (Good Manufacturing Practices). Many of these companies started on a much smaller scale but have turned into one of the best pharmaceutical companies in the country because of their commitment and dedication.
Quality Assurance
Quality Assurance covers a broad range of aspects such as batch release, qualification, validation, calibration, change control process, complaint handling, and deviation. Medicine companies in Pakistan are focusing individually as well as collectively on all these aspects to ensure the maintenance of the highest quality levels. Effective quality assurance is therefore a harmonious combination of GMP (Good Manufacturing Practices) with multiple quality systems to ensure consistent improvement in all functions of the production process.
Effective Quality Assurance ensures that:
- API (active pharmaceutical ingredients) have been produced or procured by taking into account the best practices as required by GMP. To ensure this, vendors and raw materials are regularly audited and only the best are retained.
- Control and production operations are clearly identified.
- Pharmaceutical Managers and staff are highly educated and qualified.
- Consistent evaluation and up-gradation of processes/systems are consistently evaluated and upgraded.
- Clear identification of SOP’s for optimizing operational efficiency
- Continuous updating of quality parameters with respect to GMP and other national/international standards.
- Key managers certify all production batches with respect to pharmacopeial regulations such as EP, ISP, ICH, and BP Guidelines before supplying or selling APIs.
- Satisfactory arrangements at the site for storing API products according to the required humidity & temperature conditions.
Quality Control
Quality control units of a majority of medicine companies in Pakistan comprise chemical labs, microbiological labs, stability labs, and in-process labs.
The QC departments are equipped with all the required instruments for testing finished products, packing materials, and raw materials according to the pharmacopeia requirements and CGLP (Current Good Laboratory Practices).
- Major pharma plants are equipped with gas chromatographs, UVs, particle size analyzers, FTIR, Gradient HPLC systems, Autoclaves, Karl Fisher Titrator, and COD analyzers for testing finished products such as general antibiotics, cephalosporins, and Penicillin.
- All testing in Pakistani pharmaceuticals is carried out according to Standard Operation Procedures (SOPs).
- Validated procedures are employed for monitoring and testing raw materials and products.
- Specified testing protocols for the specification of raw materials are in place.
- QC testing of all batches of Active Pharmaceutical Ingredients (APIs) according to BP and USP requirements.
- Conducting stability studies for all products before commencing commercial production.
- Highly qualified QC managers and analysts.
Compliance with DRAP (Drug Regulatory Authority of Pakistan) and GMP
The pharmaceutical sector of Pakistan is strictly regulated by the Drug Regulatory Authority of Pakistan (DRAP). From pharmaceutical industries in Lahore to those in Karachi, DRAP ensures that all pharmaceutical manufacturing units have the top standards of quality assurance and compliance with GMP. DRAP uses globally acceptable scientific standards to carry out the registration, monitoring, and evaluation of the quality, efficacy, and safety of therapeutic goods. It has separate divisions for licensing, quality assurance, biological drugs, medical devices, controlled drugs, health, pharmacy services, pricing, and OTC (Over counter) products. It has laid internationally acceptable rules for licensing, registering, research, packing, labeling, and all other aspects of pharmaceutical manufacturing.
Distribution
The entire pharmaceutical sector relies strongly on an even larger distribution network. From nutraceutical companies in Lahore to Karachi, from antibiotics manufacturers to companies manufacturing all medicinal products, from a small-scale manufacturer to Pakistan top medicine company, every medical company in Pakistan relies on this immense distribution network that supplies medicine not just to the entire country but also plays a very important role in exporting these quality medicines to other countries.
Products
The Pakistani pharmaceutical companies have been offering a wide range and nature of healthcare products. New and innovative healthcare solutions have been introduced in the last decade. The product list includes world-class anti-infectives, respiratory medicines, diabetic medicines, antibiotics, nutraceuticals, and many more. Nutraceutical companies in Pakistan have sold record nutraceuticals both nationally and globally. They include vitamins, multi-vitamins, and other supplements such as dietary fiber. In 2019, Pakistani companies exported mixed/unmixed products such as steroids, hormones, vitamins, pro-vitamins, and alkaloids amounting to 82.4 million US dollars. Exports of medicines such as antibiotics were 16.6 million US dollars. This clearly shows the acceptance of Pakistani medicines worldwide due to their quality and reputation.
Don Valley Pharma
Don Valley, a leading manufacturer & exporter of medicinal products in Pakistan has a success story like no other. This success is attributable to several factors including:
- State of the art manufacturing facility.
- Stringent quality assurance & quality control systems.
- Compliance with national and international drug regulations.
- Strict compliance with GMP.
- Effective distribution.
- Innovation.
The company has made a substantial investment when it comes to its manufacturing facility which is equipped with internationally acclaimed technology. Strict adherence to quality assurance and quality control allows Don Valley to manufacture and formulate medicines that comply not just with DRAP (Drug Regulatory Authority Pakistan) but also with international standards. The former allows the company to market its products locally while the latter has made inroads for the company in international markets. Strict compliance with GMP (Good Manufacturing Practice) has made the company one of the most progressive Pakistani exporters of medicines to other regions.
Constant innovation has permitted Don Valley to add different lines of medicines to its product portfolio including nutraceuticals, broad-spectrum antibiotics, Hematinic, cardiovascular medicines, and many more. This entire effort and struggle by Don Valley are supported by a highly effective distribution network of over 120 distributors, nationwide as well as worldwide. If the company keeps following these effective policies and practices, then there is no doubt that the latest sales of ten million dollars that it registered, will grow manifolds in the coming years and it will make an even more impactful mark on the Pakistani and international medicinal markets.