There are two types of drug molecules: innovator molecules and generics. Innovator molecules are the branded products, originally developed by some multinational pharmaceutical company through exorbitant R&D activity. These companies own patents and proprietary rights on such molecules for at least 20 years and therefore sell them on their own brand names. Because of huge expenditure on R&D, hefty marketing expenses and patent royalties, such drugs are costly. On the other hand generics are the pharmaceuticals, on which patents have got expired and nobody holds proprietary rights anymore. Such drugs are sold on their basic chemical names instead of brand names and are much cheaper due to the savings on R&D, royalty and marketing expenditure. These drugs are similar in strength, dosage, appearance, quality and other characteristics to branded drugs but do not bear a brand name. Before allowing them to be marketed, local FDA checks their bioequivalence with branded drugs and then only accords approval to them. Hence there is no cause for worry regarding their quality, safety and efficacy. However since a motley collection of struggling mom-and-pop companies have jumped into the generic trade, it has led to numerous cheap quality me-too products too from every TOM DICK AND HARY. Hence strict regulatory control and in-house quality assurance within hospital is essential to ensure their quality.
It is important to note that at present generic drugs make 75 percent of the prescription medicines sold in the United States and vast majority of these drugs are supplied either by China or India. Currently, Indian pharmaceutical companies produce between 20 and 22 percent of the world’s generic drugs, making it world leader in export of generic drugs but unfortunately its benefits are not proportionately percolating down to poor local masses who cannot afford to pay heavily out-of-pocket for branded drugs, due to several myths attached to their use. Just to cite an example one vial of generic 1gm cefoperazone + 1gm sulbactum costs Rs. 140 as against Pfizer's Rs. 500, BIPL's 458 and CMG Biotech's 456 rupees. The widely held belief that generic medicines are sub-standard is not based on facts because this notion has been nullified by a substantial number of BA/BE (Bioavailability/Bioequivalence) studies on generics. Indian generics marketed in US have also been found to be bioequivalent, having similar quality, safety and efficacy as branded drugs, by the USFDA and then only given marketing approval within US. From 2003 to 2008, in programmes supported by donor organizations like the Global Fund, Indian generic drugs accounted for more than 80% of the drugs used to treat AIDS, including 91% of paediatric antiretroviral products, and 89% of the adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets. India is also the most important source of generic drugs for cancer, heart disease, and other diseases and conditions.
Almost all drugs marketed within India are generics and not innovator molecules because none of the Indian pharmaceutical companies has actually developed them through indigenous costly R&D work. Nearly 97 percent of India’s drug market consists of second-and-third generation (generic) drugs no longer subject to patent protection in the developed world. In 1970, India eliminated patents on drug products. The new intellectual property framework enabled India to develop a strong generic drug industry and positioned India as the “Pharmacy of the developing world”. In 1994 the World Trade Organization negotiated the controversial Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). India was required to extend patent protection to drugs and to implement other new obligations. In 2005 India implemented the changes required by the World Trade Organization. In doing so, India limited patents on new uses or new formulations of drugs unless they differ greatly in properties related to efficacy. Thus when India re-instituted “product” patents, it effectively ended 36 years of protection for Indian companies and terminated legal reverse engineering or copying of patented foreign pharmaceutical drugs. For all these years Indian companies had been using copied or reverse engineered versions of original patented drug molecules of MNCs until Patents Act amendment was brought in force in 2005.
The introduction of product patents in India is actually severely constraining generic competition and supply, particularly for newer medicines. Now, there is a threat that the limited policy space that remains will be further constricted by bilateral or regional free trade agreements. Unfortunately, many free trade agreements that have been concluded or are being negotiated between industrialized and developing countries contain measures that restrict access to medicines. Current free trade agreement negotiations between the European Union and India include measures that delay or restrict competition from generic medicines, including: patent term extensions beyond the 20 years required by TRIPS; data exclusivity (that could delay the registration of generic medicines); and border enforcement measures that could block international trade in generic medicines when they are suspected of infringing patents in the countries through which they transit.
Drugs manufactured in India are classified as Branded-Generics (those generics bearing a brand name) and Generic-generics (those generics sold on their chemical names), both of which are available to the patients at the same cost, but there is huge cost difference in the two for a retailer. Therefore if hospitals purchase generic-generics directly from the manufacturer there will be cost saving for the patient to the extent of 70-80% and drugs will become available to them at as low as 10-20% of the market prices. At present only branded drugs are available in our hospital drug stores. Therefore it is high time to promote use of generics. Drug Policy of every Indian state including that of J&K clearly envisages that all drugs must be identified, listed, prescribed and dispensed only by their generic names.
One important thing to be borne in mind is that just procuring generic or branded drugs from some reputed pharmaceutical companies does not guarantee full quality, safety or efficacy. It is necessary to have stringent regulatory framework besides in-house quality control/assurance system within the hospital that can test the quality of all branded or generic drugs. Further there are some studies that have advised against using generic substitutions in case of drugs having narrow therapeutic/safety index like anti-epileptics, digoxin, warfarin, levothyroxine etc. There are also some studies contesting the therapeutic equivalence of some generics. However quality of all generic drugs cannot be simply rubbished on the basis of false beliefs and perceptions.
