It is expected that Pakistan’s first ever National Medicines Policy
would be out soon. Thanks in advance to Special Assistant to Prime Minister on Health Dr Zafar Mirza and his team of health sector experts for putting their best efforts to realizing the most needed policy framework. The nation shall be optimist that the forthcoming policy framework would pave a path for revamping of the pharmaceutical sector that could not be optimally regulated even in the presence of several national and sub-national regulations.
We may hope that the new policy framework would serve as an over-arching tool to push the existing national and sub-national regulations to perform in letter and spirit to ensure the availability of the quality medicines, and make them accessible and affordable to the general public too.
At the moment, we have Drugs (Generic Names) Act, 1972, The Drug Act 1976, with its many subsequent amendments and rules, and The Drug Regulatory Authority of Pakistan Act, 2012, Medical Devices Rules, 2017, Alternative Medicines and Health Products (Enlistment) Rules, 2014 and Bio-study Rules 2017. A number of Statutory Regulatory Orders (SROs) have been issued over the years to address emergent matters pertaining to medicines policies.
The existing sub-national or the provincial legislations include NWFP Drug Rules 1982 (with amendments in 2017 and 2018), Sindh Drug Rules, 1979 (with amendments in 2010), Punjab Drug Rules 2007, Northern Areas Drug Rules 1996, Islamabad Capital Territory Drug Sales Rules 2013, and Baluchistan Drug Rules 2018.
In February1995, Ministry of Health drafted a National Drug Policy in line with the recommendations of the Drug Action Program of World Health Organization. Though implementation of this policy hasn’t been evaluated scientifically but prima facie, it has not been followed and has not been translated into action effectively.
So this is the regulatory framework scenario in which the new policy framework has to land with a rejuvenated hope to have better access of general public to quality medicines. Interestingly, this is what we are dreaming of while our authorities have failed to monitor and check the counterfeited and substandard medicines.
Estimated that over 750 pharmaceutical companies, national and multinational, are operating in Pakistan. Among them 450 are the registered pharma manufacturing units including 28 multinationals. What others are doing?
Pakistan’s pharma market size is estimated around PKR 170 billion (2011) that is expanding at the Compound Annual Growth Rate (CAGR) of 17 per cent. Pakistani pharmaceutical industry is dominated by national manufacturers with a few Multi-National Companies (MNCs) operating in the country. A number of medicine importers are also contributing towards the availability of the medicines which are not being manufactured in Pakistan including vaccines, oncology products and certain biological products too.
At present, share of national manufacturers is about 65 per cent. Top 20 manufacturers have about 45 per cent share while 100 companies have about 97 per cent share of the total pharma market of Pakistan. They are believed to have observed the standards of infrastructure, quality system and implementation of Goods Manufacturing Practices (GMPs) up to optimal level if not completely. What about other manufacturers that are just complying with the ‘satisfactory’ standards and what about those pharma manufacturing units working below satisfactory level? Most of the manufacturer lack temperature and humidity-controlled storage facilities and adequate transportation vehicles for supply and/or transfer of medicines from their manufacturing sites. The new policy framework should address the grey areas of the pharma industry by envisaging the revamping of the entire sector.
Pakistani pharma industry is basically involved in generic products development and manufacturing with no Research & Development facilities working on finding the new medicinally active molecules. Also, there is lack of chemical industry for the manufacturing of Active Pharmaceutical Ingredients (APIs) and excipients used in medicine manufacturing, leaving the industry to rely on imports of these materials from different countries around the world, mainly from China and India.
Most of the manufacturing plants are located in Karachi and Lahore, with a few in Khyber Pakhtunkhwa, Sindh and Punjab. Medicines are sold through chemist shops or pharmacies with about 70,000 outlets spread all over Pakistan.
Supply chain of medicines can be divided into public and private sectors. In the private sector, supply of medicines is carried out by specialized pharma distribution companies along with a large number of wholesalers, helping in the supply and availability of medicines throughout the country. Certain pharma companies have their own distribution system working independently. Large distribution companies have a proper supply chain, having the storage facilities and transport vehicles as required by Good distribution practices. Most of the wholesale operations lack the adequate facilities for storage, transportation and selling of medicines, the biggest issue being the lack of controlled storage environments (temperature and humidity). Cold chain facility is available with only a few top distribution companies. Public sector supply chain is operated by provincial governments after the eighteenth amendment and is facing challenges of proper set-up and implementation at provincial level.
Creation of Drug regulatory Authority of Pakistan (DRAP) as an autonomous body was a step in the right direction to enforce Drug regulations for the improvement of all relevant areas of Pharma industry and ensure provision and availability of safe, effective and Quality medicines at affordable prices to the patients. This resulted in better facilitation to manufactures through enhanced capacity and infrastructure resulting in better licensing and drug registration process. However, to achieve the availability of quality medicines to the patients according to the vision and overall objectives of DRAP still requires significant improvement in the implementation of policies, along with streamlining of decision-making process and the timely approvals.
Same is the case of other regulations. They are there but in the shelves gathering dust. Not implemented effectively for years. We shall hope that the new medicines policy framework would bring about significantly positive change in the pharma sector of Pakistan, not only by regulating the pharma and drug regulations already existed, but the new medicines policy should incorporate a new vision – old wines should have packaged with new and refreshing tastes.
—The writer is the Director Devcom-Pakistan, an Islamabad-based policy advocacy, strategic communication and outreach consulting.