Patient groups want faster approval for low cost generic TB drugs

 Joe C Mathew   New Delhi     Last Updated: March 13, 2018  | 16:29 IST
Patient groups want faster approval for low cost generic TB drugs

Close to 90 health activists, patient groups and individuals working towards the elimination of tuberculosis have called upon Prime Minister Narendra Modi to make drug resistant TB (DR-TB) drugs affordable by ensuring supply of generic drugs.

The appeal came a day before Modi launched the Tuberculosis Free India Campaign - the mission mode implementation of a national strategic plan for TB elimination - in Delhi on Tuesday (March 13).

Although tuberculosis is gradually declining worldwide, nearly half a million people acquire DR-TB each year, which poses a serious public health challenge. In India alone, government estimates that around 1,30,000 multi-drug resistant TB patients emerge annually.

In a joint letter, the health organisations, people living with HIV and the TB community in India and across the world -- representing those affected by DR-TB -- wanted India to permit local production of two new patented TB drugs by issuing a compulsory license 'on grounds of public non-commercial' use to overcome the patent restrictions. At the moment, India is solely dependent on "mere imports that Johnson and Johnson (J&J)/United States Agency For International Development (USAID) and Otsuka donate to the TB programme in India", the letter points out.

The two TB drugs, bedaquiline and delamanid are patent protected in India till July and October 2023, respectively. Unless the government invokes the flexibilities provided under WTO's TRIPS Agreement, no other company will have the right to produce its generic version without the approval of the patent holders. Bedaquiline and delamanid adult formulations were added to the WHO Essential Medicines List (EML) for TB in 2015 while delamanid was added to the WHO EML for children in 2017.

The letter says that once the USAID/J&J donation programme concludes in April 2019, the price for a six-month course of bedaquiline in India will be $ 900 and even higher in other middle-income countries. Japanese pharmaceutical corporation Otsuka charges an exorbitant $ 1700 for a six-month delamanid course. The prices of the generic versions of patented medicines could be a fraction (fall up to 95 percent), it adds. 

Pointing out that it can take up to two years to develop and file a registration dossier with the Central Drugs Standard Control Organization (CDSCO) and the WHO prequalification programme, the letters wants the government to support the plans for the scale up and generic supply of these antibiotics to the TB programme much before patent expiry date.

These two new antibiotics, together with re-purposed drugs, are known to provide opportunities to countries with a high burden of TB to improve the safety and efficacy of its DR-TB treatment regimens and thus, prevent further infections, resistance and deaths.

Except for one instance, the government has not issued any compulsory license to cut short the patent monopoly of drug discovery companies. Even the mere scrutiny of such applications is being seen as a threat by research based multinational pharmaceutical companies. Whether the government - which has wowed to eliminate TB from Indian shores in a time bound manner -- will see this as a rare case worth considering is what remains to be seen.

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