Dear Colleagues! This is Pharma Veterans Blog Post #474. Pharma Veterans welcomes sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi onWordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
Our media is abuzz with another breaking news: “DRAP has mandated that all drugs shall be prescribed by generic names by doctors”, say the media leads shown in red to maximize the impact.
We shall look at it in three ways. One, on the merit of the available information; two, the arguments for it; and three, the arguments against it.
These are the available details.
- There is a memo from Drug Regulatory Authority Pakistan – DRAP, dated – nil – signed by Director Pharmacy Services, Dr. Abdul Rashid who has unusually put the date of 16 April below his signature.
- The reference at the top says ‘No.F.8-1/2019 DD (PS) Vol.II. (What does it signify? Was it originally written in 2019?)
- The subject is “Complaint Received Through PMDU Regarding Prescription by Generic Names of Medicines”. (The subject implies that the drugs are being prescribed by generic names, which is incorrect).
- The recipients include Secretaries Health, Karachi, Lahore, Peshawar, Quetta, Muzaffarabad and Gilgit. Chief Commissioner Islamabad is also in copy.
- The text reads, “Reference to the subject cited above, it is stated that several complaints have been received through PMDU wherein the citizens have raised concern over company influenced brand-based prescription of medicines by doctors in government and private sectors. This practice adds to the economic burden of the country and also puts financial load on patients due to purchase of pricier brands. Such practice is also against the Code of Ethics for medical and dental practitioners”.
- Paragraph two reads, “You are therefore requested to take necessary measures for promoting generic prescriptions by doctors and discourage the practice of incentivized prescription in the best interest of the patients and the country”.
There are several inconsistencies related to the above communication, which are pointed out below.
- DRAP is the custodian of the Pharmaceutical and healthcare products, medical devices, supplements and nutritional products. It is mandated to formulate and enforce policies in its scope of work.
- DRAP is authorized to grant registration of drugs, healthcare products and medical devices, which it does after due process of scrutiny.
- DRAP currently works under the ambit of Drug Act 1976 and DRAP Act 2012. Under relevant clauses, it is customary to issue Drug Registration Letters by brand names of drugs.
- Changing the drug names from Brands to Generics requires amendments in the Drugs Act which is the responsibility of National Assembly.
- After the passage of 8th Amendment, the function of Health has been devolved and given to provinces. DRAP is a central body and should not get involved in provincial matters.
- Generic Drug Policy was rolled out in !973 by the then Health Minister, Rasheed Sheikh. It changed the drug names from Brands to Generics across the board. When I started working, it was in the era of Generic policy.
- The Generic policy did not work as envisaged due to several missteps in its execution.
- At that time, Pharma market was overwhelmingly dominated by the MNCs who exerted pressure on the government to revert to brands. It was in their interest.
- The government gave in and in April 1976, the new Drug Act was enforced which reinstated brands.
- Since last 45 years, brands have been reigning supreme and more than 100,000 branded products have been further registered.
- A simple memo, like the one referred above, cannot possibly stop branded-generics and start generic-generics.
- If DRAP is really serious about this move, then it would need suitable amendments in the Drug Act 1976 which is still the governing document.
- Our media in its desire to get public attention by way of sensationalizing, has created an impression that DRAP has brought a new law which bans prescription by brand name and directs to prescribe by generic name only. No such thing has happened as yet. The only document is the memo produced above.
- DRAP may be trying to test the ground through sending this feeler. It may be thinking about bringing this change. However, this method is neither graceful nor effective.
To be Continued……Disclaimer. Most pictures in these blogs are taken from Google Images which does not show anyone’s copyright claim. However, if any such claim is presented, we shall remove the image with suitable regrets.