Subject;- Granting of CL for Bedaquiline and Delaminid
We the undersigned learn from media report that two important drugs (Bedaquiline and Delaminid manufactured by Janssen of the USA and Otsuka of Japan) needed to treat Drug Resistance Tuberculosis (DR TB) are not available to Indian patients. Both the drug companies are ready to donate the medicines but it well known from previous experiences that such “donations” are only an excuse for the drug companies to tighten the grip over market and thus keep the drug price high. This will only keep the medicines away from the reach of the needy. Unfortunately the drug manufacturing companies are not even ready for voluntary licensing.
This leaves with only one option for India and that is granting of Compulsory Licensing (CL). According to a study published in Bulletin World Health Organization 2018 “found that countries made extensive use of TRIPS flexibilities between 2001 and 2016. This was previously unreported. The most frequently used measures were compulsory licensing, public non-commercial use licensing and the least-developed countries pharmaceutical transition measure, which together accounted for 79.5% (140/176) of instances. To date, the most comprehensive, published database lists 34 potential compulsory licences in 26 countries”.
This particular study establishes the fact that CL has been used by countries all over the world and so India has every right to use it under TRIPS flexibilities. It has also been a matter of concern that when the Indian generic drug company NATCO was granted CL, it subsequently faced several hurdles all created by MNC. But that should not deter Indian government from granting of CL
India needs to take bold steps so that the last person in our country is taken care and towards this granting of CL for two much needed Resistance TB medicines will be an important step.
Hoping to hear from you positively.
Dr Gopal Dabade (9448862270), Dr SL Pawar (9449354415),
Mr S R Hiremath (9448145930), Dr SC Bangalore (9482235427)
DRUG ACTION FORUM – KARNATAKA
57, Tejaswinagar, Dharwad 580002. 0836-2461722