The Drugs Controller General of India (DCGI) has approved two indigenously developed new chemical entities - an anti-cancer compound codenamed DRF 1644 from Dr Reddy's Laboratories (DRL) and an anti-infective developed by Wockhardt Ltd- for Phase -1 clinical trials, it is learnt. The DCGI nod follows the recommendation of Dr. N. K. Ganguli Committee for investigational new drug applications (INDAs).

A DRL spokesperson told Pharmabiz.com that the company filed the INDA for DRF 1644 in September 2001. "The compound belonging to oncology therapy segment is a topoisomerase I inhibitor. It is active both orally and intravenously with a very positive pharmaco-kinetic profile," he informed.

The anti-bacterial from Wockhardt, sources said, is specifically designed for treating staphylococcal infections. It is in the parenteral form. Wockhardt, a recent entrant in the area of new drug discovery, is in the process of discovering new antibiotics and anti-infectives. The molecule that has now been cleared for clinical trials is one amongst the two anti-bacterial compounds the company's R&D wing has developed.

While the anti-infective would be the first NCE from Wockhardt to enter clinical trials, DRL has got three compounds in clinical trials including anti-diabetes compounds (insulin sensitizers), DRF 2593 and DRF 2725 licensed to Denmark-based Novo Nordisk and anti-cancer NCE, DRF 1042. While the two insulin sensitisers are in Phase 2 and Phase 3 trials respectively with the Danish multinational, DRF 1042 is in Phase 1 clinical trials in India.

Signalling the capability of Indian companies in NCE development, the Drug Controller's Office is receiving increasing number of IND applications form Indian companies, source said. It is learnt that amongst the INDAs now under consideration include Ranbaxy Laboratories' compound for treatment of bronchial asthma and an NCE filed by Kopran Ltd, which is the first such product from the company.

While the drug control authorities have lately introduced a free structure and set up a committee for evaluating these applications, a timeframe for clearing the applications is also on the cards. As per this, the decision on application for Phase 1 would be taken within three months of filing of the applications. Besides, the Schedule Y of the Drugs & Cosmetics Act that deals with clinical trial protocols is being revised to allow Phase 1 and Phase 2 trials for products of foreign origin.

At present, only Phase 3, which is regarded as less risky is allowed in India for such products and first two phases are limited to products of Indian origin. The CT protocols describe the type of people who may participate in the trial, the schedule of tests, procedures, medications, dosages and the length of the study.

A process is also on to strengthen the regulatory environment in the country to develop and improve domestic expertise and facilities for evaluation of new drugs through toxicity studies, clinical pharmacological trials and pharmaco-kinetic evaluations.