In order 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.
According to the new order given by India's top drug regulator, "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. 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."
"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.
The notice by G N Singh, the Drugs Controller General of India (DCGI) said, "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 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.