|
Indian procurement agencies need to assure quality of medicines and medical devices: Suresh Saravdekar
|
|
Nandita Vijay, Bengaluru
June 29 , 2021
|
|
|
Indian medicine procurement agencies need to put in place a correct pre-qualification criterion to make a choice of assured quality medicine, according to Suresh R Saravdekar, vice- chairman-hospital division, IPA.
The reality of Indian pharma industry is that it is the battle for market share for generics versus branded formulations. Brand name and also least priced generic drugs are not necessarily assured of quality but only assumed quality. Hence it must be the endeavour of the government and private healthcare agencies to obtain quality assured drugs in a competitive manner, he added.
Speaking on the topic Generic Medicines – Myths & Facts and How to get a “Quality Assured” Generic Medicine from market of “Quality Assumed” Medicines, Dr Saravdekar said Medicine choice is a third party decision. Even if the patient is the consumer, physicians and procurement agencies select which medicine in treatment. Patients are thus dependent on physicians, procurement managers in the hospitals and pharmacists who prescribe, supply and dispense medicines respectively. Thus the procurement of medicines is a third party decision, he added.
In India, it is the Central Medical Services Society (CMSS) which is an approved Central Procurement Agency (CPA) to ensure timely and un-interrupted supply of pharmaceuticals and medical devices for Jan Aushadhi stores. All these procurement agencies including central government for Defense, ESIs, DGHS , Railways, and state healthcare services, must have complete knowledge and information about the competitive medicine market and various marketing strategies adopted by pharma companies, Dr Saravdekar pointed out.
Quality of a generic or branded formulation of the same medicine in India differs. This is because of varied standards like WHO GMP only for export and non-WHO GMP for domestic market .There are various licenses too. For example, when it is own license , the owner is 100% liable and can be prosecuted if product is declared of substandard quality.
However this is not the case with third party manufacturing as the product license holder is merely a marketing agency getting products manufactured. Similarly, in case of generic medicines the quality can be of three types: chemically equivalent generic, bioequivalent generic and therapeutic equivalent. All these issues related to quality of medicines led to the introduction of pre-qualification criterion in tenders like licenses for own, WHO-GMP and bioequivalent to select a quality assured medicine, he said.
Quoting a report, Dr Saravdekar said there is also an issue of rational drug selection. Currently, of the total drugs entering the market, only 14% are innovative and 86% are similar to the existing ones. “All innovations are targeted towards ‘Me Too Drugs’, fixed dose combinations (FDCs) and of diseases prevalent in developed countries. No novel drugs are there for tuberculosis, malaria,, leprosy, amoebiasis, Dengue, Chicken Guinea, Japanese Encephalitis and no effective medicines are available for Kala Azar.
Drugs are introduced after clinical trials assure it is safe for use in patients. But pharmacovigilance and post-marketing surveillance should be in place because medicines always carry a risk of some inherent, un-noticed problems, known as adverse drug reaction (ADRs), said Dr Saravdekar.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|