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4th May, 2017
Generic Drugs: IMA Perspective
Dr KK Aggarwal, IMA National President 
(With contributions from Dr RN Tandon, Dr A Marthanda Pillai, Dr Vinay Aggarwal &   Dr RV Asokan)

Preface
Hon'ble Prime Minister, Sh. Narendra Modi Ji has said that the Government is contemplating a legislation that will make it mandatory for the registered medical practitioners to prescribe generic only drugs (generic- generic drugs or writing a generic drug without brand name).

IMA, in principle, welcomes usage of generic-generic drugs, yet has very serious concerns regarding quality assurance and other complex issues involved.

To understand the whole issue, we first need to understand various terms used in the law In India, a generic drug can be marketed with following business model:-
  1. Generic-Generic or Generic-only drug (without brand name) and usually is supplied in institutional supplies. "Generic name of the drug" is not same as generic drug and means the chemical name of the drug only. Generic-Generic is made and marketed by local companies in the unorganized sector as the preparation with questionable quality.
  2. Trade Generic (Generic marketed under a brand name) and usually is marketed and promoted through the trade chemists in the unorganized sector without any Medical Sales Representative and other Marketing Staff, no R&D set up, Lack of current Good Manufacturing Practices (cGMP) assurance in manufacturing plants with high margins to the chemists etc.
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Tuberculosis still a cause for concern
About 45% of the multi-drug cases are from India and two other countries

New Delhi, 03 May 2017: According to a report by WHO, India has 27% of the world's new tuberculosis (TB) cases. TB is one of the biggest infectious diseases in India. The country accounts for a high number of worldwide TB cases due to which the global estimates have also gone up from 9.6 million to 10.4 million. Apart from this, about 2.5% of the new TB cases are resistant to Rifampicin, or to both Rifampicin and Isoniazid, the two most commonly used anti-TB drugs. 
 
About 45% of the multi-drug resistant TB cases in the world are from India, China, and the Russian Federation. Although TB is treatable, treatment reaches only 59% of the estimated TB patients in India.
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