Rules eased for HIV, Hep B & C combo drugs

NEW DELHI: With an aim to make new combination drugs for HIV and Hepatitis B & C available to patients at the earliest, the government has decided to waive some of the regulatory processes to fast-track approvals.

India’s top drug regulator has said in a new order that companies manufacturing combination drugs for HIV and Hepatitis B & C can seek early approval with a WHO recommendation even if internationally the medicines are not approved as a combination but only individually. However, the drugs have to be relevant for India.

“Many of these combination products, recommended in WHO guidelines for concomitant use, may not have been approved internationally in combination but may have been approved individually. However, given the risk-benefit and recommendations by WHO the requirement of generated data may be waived based on the fact that the product has been recommended for concomitant use by WHO,” the notice by G N Singh, the Drugs Controller General of India (DCGI) said.

The move is expected to benefit many of the over 21 lakh people estimated to be living with HIV in India. Moreover, viral hepatitis has also been recognised as a serious public health problem in India by the World Health Organisation (WHO) with a total of over 52 million people infected with chronic hepatitis in the country. Out of this, 40 million people in India are chronically infected with Hepatitis B and 6 to 12 million people are chronically infected with Hepatitis C, latest assessment by the UN agency shows.

The regulator has also allowed leeway to manufacturers for conducting clinical trials or bio-equivalence studies in India. While these studies are conducted to test new drugs on local patients, they take a long time and hence often delays launches in the country.

The new norms issued by the regulator allows companies to apply for such studies and product approvals simultaneously, whereas usually companies have to submit data from trials before seeking product approvals.

In fact, in some cases the regulator has also suggested waiving off clinical trials for urgent use.

“Clinical trial waiver for such products recommended by WHO for concomitant use may be given, as being falling under the category of extreme urgency and under the provisions of the Drugs and Cosmetics Rules,” it said.

Though India has demonstrated a 57% reduction in overall annual number of new HIV cases, it continues to have the third highest number of people living with HIV in the world. Similarly, chronic Hepatitis is placing a huge disease, social and economic burden on affected families as well as the health system. The condition can be self-limiting or can progress to liver fibrosis (scarring), cirrhosis or liver cancer.

Early approvals in India are also likely to benefit people around the world as India is a major supplier of generic medicines, mainly anti-retroviral.


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