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Reference Countries – DRAP considers reference countries from three angles.
One, there is a list of countries from where prices of similar drugs are taken, and a basket price is determined which becomes the basis for price fixation in Pakistan. It was mentioned in the previous blog also.
Two, all new applications for registration are checked against availability in the SRA (Stringent Regulatory Authority) countries. These include US, EU, UK, Japan and Australia. If a drug or combination or dosage form is not available in SRA countries, the DRAP rejects the application promptly. On one hand, it means there is no room for innovation in Pakistan; on the other it means that our demographic standing is considered at par with highly developed countries. Both premises are unsustainable.
Three, if the manufacturer is located in an SRA country, DRAP would grant registration of imported drug without inspection of plant; for all other countries, plant inspection by DRAP inspectors is mandatory for registration. It is a good process if done on time and by qualified people.
DRAP also desires that generic drugs be developed in line with the innovator drugs. It is a noble cause as it will ensure that the patient taking a generic drug shall have similar efficacy as that of innovator drug. However, when it comes to pricing, DRAP conveniently forgets that the development of newer drugs on the pattern of innovator drugs is quite costly. The prices granted to generic drugs are mostly dismal.
There are several instances where DRAP overrules availability in SRA countries. For example, L-methylfolate tablets are available in 7.5mg and 15mg strengths in the US. There are published studies showing its benefit in psychiatric patients, but DRAP has consistently refused to register it. Similarly, probiotics have been freely available in all so-called SRA countries. When these were applied in Pakistan, the then Ministry of Health kept sitting on it for two years and later said it was out of their scope.
It looks like that DRAP has its own logics which are sometimes guised under SRA countries and sometimes as DRAP logic.
The reason says that all countries need to watch their own interests. Our close neighbors India, Bangladesh, Iran, Turkey do not follow the SRA countries. They develop their own combinations and their regulatory authority approves it for sale. Same is true for dosage forms.
Dosage forms or Drug Delivery Systems are the newest fashion in Pharma industry. The innovator companies are developing more and more complex drug delivery mechanisms. These are not compared to conventional systems to show if they are really superior. Only the hype is created around a highly innovative drug delivery mechanism, the intent of which is actually to discourage competition early. While our neighbors are not always impressed, our DRAP is always in awe and insists that generic drugs must be made on similar pattern. One example shall clarify the point. Olanzapine is a drug indicated for psychiatric conditions like schizophrenia. There used to be a straightforward tablet from the innovator company. Later, they brought a new form which is made in a highly complex manner. First a liquid is made and filled in the blister bubbles, then it is passed through liquid nitrogen which freezes it instantly, then it is freeze-dried and packaged. The pretext is early bioavailability; availability of drug in the blood to show effect. It may be so, but the point is that psychiatric drugs take several days to show effect; early or late bioavailability is not of any serious consequence.
In the Indian Patent Act, there is a clause called ‘Prohibition of Evergreening’. Evergreening is defined as an effort to make minor changes to an old product to continue getting new patents. Indian Supreme Court has been rejecting ‘violation of patent’ petitions on this basis; we would not.
DRAP has issued another rule. Generic formulations of new molecules must do major R&D and submit data to get registration. They also want that the generic formulations be compared with the innovator products, most of which are not available in Pakistan. How and from where to get innovator product is not DRAP concern; it will not support in any way. It is a huge hassle faced by all generic manufacturers trying to develop generic versions of newer drugs. There is a cost of R&D which in some cases is quite large. Take example of Lurasidone, another psychiatry drug. Only the impurities testing costs around 2,000,000 rupees. Add other costs and the company ends up spending over 3,000,000 rupees to develop the product. MNCs claim they spend close to a billion US dollars on Research & Development of a new product. But they get premium price to cover R&D cost incurred, and to-be-incurred for next new products. The first couple of companies who got a generic version of Lurasidone got a selling price which barely met their manufacturing and selling expense. They would not recover their R&D cost, probably never. Why would anyone spend so much money and send it down the drain? Beats any reasonable person.
The summary is that all the talk around SRA countries is not sustainable on logical grounds. This could be used more reasonably for the benefit of public at large.
To be continued……