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Government decide to ease rules for HIV, Hep B & C combo drugs

 

Clinical courses

In order to make the new HIV and hepatitis B and C drugs available to patients at the earliest, the government has decided to abandon some of the regulatory processes to accelerate approvals.

India's leading drug agency said in a new order that companies manufacturing combined HIV and hepatitis B and C drugs may seek early approval with a WHO recommendation, Have not been approved as a combination. However, the drugs must be relevant to India. The move is expected to benefit millions suffering from HIV and hepatitis in India.

"Many of these combined products, recommended in the WHO guidelines for concomitant use, may not have been approved at the international level in combination, but may have been approved individually. However, taking into account the risk-benefit ratio (analysis) and WHO recommendations, should be waived due to the fact that the product has been recommended for concomitant use by WHO, "stated the opinion, published By GN Singh, India's Comptroller General of Drugs (DCGI).

The new standards allow companies to simultaneously request such studies and approvals of products, whereas test data are generally required before seeking approval. In fact, in urgent cases, the DCGI also suggested renouncing clinical trials.

 

The DCGI has also allowed manufacturers to give free rein to conduct clinical trials or bioequivalence studies in India. These studies are conducted to test new drugs on local patients, and take some time and therefore often delayed launches in the country.

Although India has demonstrated a 57% reduction in the annual number of new HIV cases, it still has the third largest number of HIV-infected patients in the world. Similarly, chronic hepatitis poses an enormous social, economic and social burden to affected families and the health system. The early approvals here are also likely to benefit people worldwide as India is a major supplier of generic drugs, mainly ARV one.

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