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Exploring generic medicines wisely

Dr Jayant B Dave
Wednesday, June 07, 2017, 08:00 Hrs  [IST]

The word ‘generic medicines’ has become a buzz word not only in developed countries but in our country too. The concern shown by the Government and other statutory bodies like Medical Council of India for prescription and dispensing of generic drugs in India however well intentioned is not wise enough. This is a complex subject involving several scientific, regulatory, social and economic dimensions and has to be looked into its entirety for the good of the healthcare profession and nation at large.

To begin with, the Government and the pharmaceutical industry deserve all credit for development of pharmaceutical industry as manufacturer of global reckoning with over 10,000 units and 1,300 of them being WHO-GMP approved and many of them being the US FDA & MHRA approved. The country is slowly but steadily making headway into research and development for developing not only generic drugs but innovative formulations to keep pace with the demands of time in the national and international market. This is attributable to several initiatives taken by the Government over the years like Indian Patent Act, Drug Prices Control Order and thrust laid on exports. The industry has also matured and evolved scientifically, technically and strategically. It cannot be denied that price of modern medicines is the lowest in India compared to even all neighboring counties. We should therefore march forward with a larger vision and should desist from taking any course that may unknowingly weaken the progress made by us thus far. The credit also goes to pharmaceutical trade for making medicines accessible to interiors and benefiting about 50 per cent of population.

It is important to understand the difference between generic name and generic medicines. Generic Name is an International Nonproprietary Name (INN) assigned by WHO. Besides, some countries such as United States, Britain and Japan have their generic/approved names. This, generic name is for Drug Substance.  When any innovator drug company develops a suitable product (conventional tablets, capsules, injections or new drug delivery system like nanopreparations, inhalation preparations involving one or more drug substance/s, it becomes new drug product referred to as innovator or reference product and this branded product usually acquires exclusive patent rights. When any other company develops a pharmaceutically and biologically equivalent product and generally markets after the expiry of a patent, it is referred to as generic medicine.  In countries like United States, this is marketed with generic name of drug like Amoxycillin and Clavulanate tablets and does not bear a brand name. The pharmacist is empowered to dispense any generic formulation unless the doctor writes POM - Prescription Only Medicines

In India the situation is somewhat different. Since product patent became operational from 2005, most products marketed in India up to 2005 never acquired product patents and we did not experience the brunt of patents – thanks to Indian Patent Act 1970 and 2005. In other words, most products marketed in India at present are generic medicines only. About 80 per cent of them (about Rs 80,000 crore) are marketed as branded generics by small, medium and large pharmaceutical companies and 20 per cent (Rs 20,000 crore) are used with generic names only mostly in Government healthcare set ups.

Thus, we live in the world of generic medicines only. In India, the world generic is used in one more sense of marketing type. When products are marketed with promotion to medical profession, It is called ethical marketing (for name’s sake) But, when the products are sold directly from chemist’s shelf either by chemist’s own dispensing or substitution of a pharmaceutically equivalent product, they are referred to as generic medicines. Here, chemists are entitled to much higher margins as there is no promotional cost. But, here again printed maximum retail price (MRP) is same and they also bear brand names.

In essence, most medicines available in trade are branded generic medicines differing only in marketing styles. What Government probably wants the most is rationalization of pricing. The Government has already in place a very active National Pharmaceutical Pricing Authority (NPPA) administering Drug Prices Control Order regulating price of all essential medicines required for medication and even capping the price of non-regulated products. Hence, there should be no need for insisting on prescription by generic name with a view to regulate pricing.

Yes, the list of essential medicines can be expanded or any other medicines can be brought under price control ambit wherever and whenever thought proper.  Besides, mechanism of price fixation may be reviewed and necessary changes made from present system of averaging market price. The cost based formula may also be applied or some other mechanism evolved to rationalize the price of drug products.

Where is therefore the need on the part of Medical Council of India to provide a mandate to doctors prescribe drugs in generic name only by amending clause 1.5 of code of professional conduct, etiquette and ethics or need on the part of government to propose an amendment to the law to empower pharmacists to substitute brands with generic versions. Presently, pharmacists cannot legally replace the prescribed medicines/items falling under Schedule H and X as per the Rules 65(11) C of the Drugs and Cosmetics Rules 1945.

Apart from regulatory, there are some technical and scientific considerations that need to be looked into. Manufacturing product permission has been granted over the years with brand names by State Licencing Authorities (SLA). Of late, product permission for a formulation containing single ingredient is given with generic name but permission for a fixed dose combination (FDC) containing one or more active ingredients is given with a brand name. In either case, manufacturers are manufacturing the products with their brand name printed below the generic name and hence even if doctors are made to prescribe in generic name, the customer will end up receiving a product with some brand name only. Another very relevant point is that about 50 per cent medicines prescribed and used in India are fixed dose combinations containing one or more drug substances and prescriber will neither remember all the ingredients and their content in mg or neither mcg nor it is practically feasible to write them all. As regards Ayurvedic proprietary medicines, health supplements and neutraceuticals, prescribing in generic names would be virtually impossible as they contain several ingredients and names of ingredients are not commonly known to doctors and pharmacists. Writing brand name would be easier and less prone to occurrence of prescription, dispensing and administration errors.

In India, there are large number of manufacturers from micro to large scale with huge differences in scientific acumen, infrastructural capabilities and professional commitment and it is simply naïve to assume that the different brands for any given composition marketed by different companies are equivalent and any of the brands may be used without concern for safety or efficacy. Various brands of a given formulation are not even pharmaceutically equivalent, let alone bioequivalence. Formulations vary significantly in pharmaceutical performance test like dissolution for relatively insoluble drugs, impurity and assay tests in case of relatively unstable drugs like coamoxiclav and rabeprazole tablets. We must admit that there is a substantial difference in quality of drug products of even same company marketing to developed countries like United States/European Union and in India on similar counts. The content of active ingredients and impurities may be comparable in freshly prepared batches of different brands but they will perform differently with time based on stability of the products.

Doctors choosing the brands may lead to good and bad incentives offered to the doctors and resultant unwarranted prescriptions and escalation of costs. But this can be mitigated by measures like effective and if need be, extended price control and schemes like Pradhan Mantri Jan Aushadhi Yojana where maximum retail prices are fixed under the scheme and product is sold at specified price as per the tag placed thereon regardless of the brand name and printed maximum retail price there on. What we have failed to recognize is that doctors’ choice for a brand is also determined by the efficacy and safety of a medicine judged by a doctor during the clinical practice. No sensible doctor would prescribe any brand on a regular basis unless he/she gets the required result. If this privilege of choosing a brand is passed on from a doctor to chemist, only commercial considerations will prevail and we shall be deprived of the vital indirect role played by the doctors in validation of a product quality.   

Bioequivalence meaning rate and extent of availability of a drug to a biological system ascertained by time versus blood concentration study is a very vital subject.  When bioequivalence is achieved over and above pharmaceutical equivalence, one achieves therapeutic equivalence. This is achieved in developed countries like US before granting permission to Abbreviated New Drug Application (Generic formulation) and replacement of a generic medicine in lieu of a branded innovative product is justifiable. In India, Bioequivalence study is required to be performed in many products for getting approval of new product for the first time and then up to four years thereafter. After four years of its first approval, the product ceases to be a new drug and manufacturing permission is given only on the basis of in vitro (outside body) tests like dissolution in suitable media. This is very pragmatic indeed.

Here again the Government is making another ambitious decision vide GSR No 327 (E) dt 3.4.17 is to make bioequivalence study testing compulsory for drugs falling under Biopharmaceutical Classification System (BCS) Class II & IV which have low aqueous solubility even drug product ceases to be new drug. The proposed change is scientific and well thought out. But its sudden implementation is not feasible and wise due to various reasons illustrated by Indian Drug Manufacturers Association in its submission to the Central government. To cite some important points- it is very difficult to identify Reference Listed Drugs (RLD) in India as per the present regulatory system against whom bioequivalence study can be performed, lack of control on post manufacturing changes, lack of adequate expertise on the part of state drug licensing authorities to evaluate the bioequivalence data, inadequacy of approved CROs performing bioequivalence studies and huge cost of clinical testing, etc.

What is the way out?
The Government of India should appoint a committee of experts and seek a report within stipulated time and maintaining status quo until final decisions can be reached. The GSR on BCS should be held in abeyance.  One of the meaningful solutions can be that the doctors should be made to prescribe in generic name along with a brand name of their preference and chemists may be allowed to make replacement of brand in respect of drugs that are relatively safe for substitution from the standpoints of stability & bioequivalence and listed in one annexure and having some mark on a product packing like a green line on the left hand side. The world is witnessing us and let us evolve an ideal Indian model of generic drugs. We are the leader of generic drug manufacturing benefitting the whole world.. There is no reason why we cannot bring benefit of generic drugs to our own countrymen. The views expressed are writer’s own considered views.

(Author is Vice President, Indian Pharmaceutical Association, Gujarat State Branch & Member of IPA-Centre Industrial Pharmacy Division)

 

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