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Disconnect from Reality – Like many other areas, the government administration and departments are disconnected from reality while making policies in the healthcare sector. At times, it appears that this disconnect is deliberate; at other times it is just there. Some examples will illustrate this point.
- Pakistan does not have any USFDA approved pharmaceutical plant till now. As far as is known, no company is even going in that direction. USFDA requirements are difficult to meet. Starting from the site to design of manufacturing unit to processes to materials to documentation, specific conditions are to be met to qualify. DRAP approves the site, approves the layout and everything else. DRAP expectation is that the local manufacturers comply with cGMP – current Good Manufacturing Practices as laid out by WHO universally and adapted by countries as per their local conditions. The cGMP standard in Pakistan and other countries is a far cry from the conditions put up by Stringent Regulatory Authorities (SRA) such as USFDA, MHRA of UK, TGA of Australia, EMA of EU etc. All the multinational companies operating manufacturing units in Pakistan also comply with the local cGMP only; none qualifies for SRA standards. Even then, all government institutions ask for international certification while floating purchase inquiries. Several years ago, provinces issued detailed rules for purchase of medicines and related items by government hospitals and institutions. All of them have clauses asking for SRA qualification and giving greater rating if you have it. Question is, when no one in Pakistan has it, why is this clause included? Either it is a disconnect from reality, or an effort to favor certain imported drugs.
- Active Pharmaceutical Ingredients (APIs) or simply raw materials are mostly imported in Pakistan. Pakistan has five units manufacturing less than twenty APIs in limited quantities; most APIs are therefore imported. There are two major sources in the world for buying APIs; India and China. There are very few other sources located in Western and Eastern Europe which offer very selected APIs. The Pharma Industry in Pakistan and all over the world largely runs of APIs from China and India. The APIs specifications compliance is gauged in two ways. One is compliance to International Pharmacopeias; USP is US Pharmacopeia; BP is British; JP is Japanese; EU is European and so on. Countries may have their local Pharmacopeias, but these are not recognized. All APIs must conform to an international Pharmacopeia. Second compliance is to SRA specifications. It means that like drug manufacturing units, the API manufacturers also get certified from one or more SRA countries. So, the APIs may in addition to USP also comply with USFDA standard. The prices vary significantly due to compliance standards; the SRA standard APIs may have many times more prices. When DRAP fixes the selling price, they do not consider the source of API. Though the price difference is well known, the price fixation is in utter disregard of this factor.
- The government institutions while purchasing medicines ask for API source also and give higher rating for SRA standard. However, when it comes to competing for prices, the lowest quoted prices are accepted. There is no consideration for API source at that time. This is a common contradiction seen every day.
- Pharmaceutical manufacturing units are scattered all over the place. Although, some conditions should be met for site approval and DRAP looks at that, but many units are located at sites which are or have become unsuitable for running a Pharmaceutical Manufacturing Unit. There is no effort from DRAP to address this issue. In isolation, DRAP is raising its own bars without regard to ground realities.
- Regulatory authorities such as DRAP, USFDA, MHRA, TGA, EMA have dual role. They do the policing to ensure that compliance to laid down standards is done; and they also make sustained efforts to upgrade the industry standards through training, advice and support. DRAP has arranged some training courses with the support (and funding) of WHO, but these do not help in raising industry standard.
- Government departments’ functioning in Pakistan and other such countries is deliberately designed to create dominance and unnecessary pressure on people. DRAP is no exception; its staff and functionaries are tilted towards creating hurdles for people rather than facilitating.
The summary is that there is total disconnect between the desired standards and practices. It is so significant that there is no way to bridge this gap.
To be continued……