Regulatory bodies on Generic medicines

In order to have a complete trust in Generic medicines before using them, we need to check what the regulating body for food drugs has to say about generic medicines.

                      In India, drug manufacturing, quality and marketing is regulated in accordance with the Drugs and Cosmetics Act of 1940 and Rules 1945. Over the last few decades, this act has undergone several amendments. The Drugs Controller General of India, who heads the Central Drugs Standards Control Organization, assumes responsibility for the amendments to the Acts and Rules. Other major related Acts and Rules include the Pharmacy Act of 1948, The Drugs and Magic Remedies Act of 1954 and Drug Prices Control Order 1995 and various other policies instituted by the Department of Chemicals and Petrochemicals.

                Generics have an important role to play in public health as they are well known to medical community and usually more affordable due to competition. They are formulated when patent and other exclusivity rights expire. The key for generic medicines is their therapeutic interchangeability with originator products. To ensure the therapeutic efficacy generic products must be pharmaceutical interchangeable (contain the same amount of active ingredient and have the same dosage form) and bioequivalent to the originator product. Bio equivalence is usually established using comparative in-vivo pharmaceutical studies

                                                The generic drug companies in India have broad technological and diversified market capabilities. As more and more patents expire, the generic portion of the pharmaceutical market is expected to continue to have increased sales. The scientific capability for manufacturing and supplying generic drugs of these companies will give them an edge over others and make them major players in the international generics market. Fortunately India has the best subject skills to galvanize foreign investors. The encouraging scenario of basic research and drug discovery will also support the changed dynamics. But their future sustainable growth depends on sustaining in competitive markets of developed world. The major challenges for generic manufactures are strengthening the existing regulatory system especially for enabling more detailed and universal classification of drugs and chemicals between branded generic and generics. High R&D cost and investment in research is also a major stumbling block in this direction

Future Generic Drugs

Future Generic Products in India and US It is seen that there is an upward swing in the generic market. It has reached 100 billion dollars in the past and is estimated to be three times higher than the overall growth of drugs. The current trend exhibits that blockbuster drugs are scheduled to lose their patent protection, opening the doors to cheaper generic drugs between 2013 and 2015 with the total market value in billions. It is expected that the percentage of generic drugs in the US market will rise from 14 to 21. This growth will enhance the export prospect of India and it will be doubled every year. It will be due to increase in the number of low cost workers and degree of innovation. Recent success in track record in design operation of high tech manufacturing, testing, quality control, research, clinical testing and biotechnology also contribute to this higher growth. Indian pharmaceutical industries those who have USFDA (United States Food and Drug Administration) affiliations and approval of ANDA (Abbreviated New Drug Applications) will stand benefited. Now India’s global share in the field of generic market is stipulated at 35% which is very high [6,7]. Table 3 describes list of various drugs going to get off-patent in 2015. To make the situation more favorable the Indian government has also introduced scheme of providing generic drugs to patient in hospitals with various Jan-Upanishads Kendra (Facilitation Center). Thus future prospects of generics in India and US are very high as they are the next big thing in health care scenario. Consistent with prior research, MEPs (Market Exclusivity Periods) for drugs experiencing initial generic entry in 2011-2012 was 12.6 years for New Molecular Entities (NMEs) with sales greater than $100 million in the year prior to generic entry, and 12.9 years for all NMEs. Further research may reveal variation by type of NME, whether defined by molecule type or other classification. Generic competition has intensified over the past 10-15 years, and the MEP has become an even more important indicator of the economics of brand-name drugs. The MEP is critical to manufacturers’ ability to earn profits on brand-name drugs to fund future research and development activities, and brand-name drug shares rapidly drop following initial generic entry. Over 80% of brand name drugs experiencing initial generic entry in 2012 had faced at least one Paragraph IV patent challenge from a generic manufacturer, up from only 9% for drugs experiencing initial generic entry in 1995. These challenges are filed relatively early in the brand drug life cycle, on average within 7 years of brand launch. Developments for the generic pharmaceutical industry are encouraging as more brand-name drugs come off patent and payers push for cost cuts in health care