Tag Archives: ICMR

NATIONAL: MEDICAL RESEARCH : The Indian Council of Medical Research (ICMR) completes Clinical Trials of World’s First Injectable Male Contraceptive; study claims it’s safe

The findings of the phase-III clinical trial, which involved 303 candidates aged 25-40 years, were published in the international open-access Andrology journal last month.

The Indian Council of Medical Research (ICMR) has completed the clinical trials of the world’s first injectable male contraceptive which showed that it is safe and highly efficacious without any serious side effects.

The findings of the phase-III clinical trial, which involved 303 candidates aged 25-40 years, were published in the international open-access Andrology journal last month.

The open-labeled and non-randomized, multi-centre hospital-based phase-III clinical trials were carried out at five different centres (New Delhi, Udhampur, Ludhiana, Jaipur and Kharagpur) and coordinated by the ICMR, New Delhi.

Permission to conduct phase-III clinical trial was granted by the Drugs Controller General India (DCGI) and approved by the institutional ethical committees of the respective centres.

As part of the study, 303 healthy, sexually active and married men and their healthy and sexually active wives who came to the family planning clinic and department of urology or surgery for vasectomy or No Scalpel Vasectomy (NSV) were identified.

The men were injected with 60 mg of Reversible Inhibition of Sperm under Guidance (RISUG).

“The overall efficacy of RISUG with respect to achieving azoospermia was 97.3 per cent and based on pregnancy prevention was 99.02 per cent without any serious side effect,” the study stated.

“In the history of contraceptive development, RISUG presents the highest effectiveness compared to all other contraceptives both male and female as they were at the threshold of induction into a mass contraception program,” it said.

According to the study, with an ever-increasing world population, there is an urgent need to develop modern methods of male contraception for population control.

Even though vasectomy is quite effective as a contraceptive measure, some major limitations of this method call for the development of improved techniques.

An ideal male contraceptive approach should have minimally invasive drug delivery system with a one-time injection, long-term effectiveness with negligible side-effects and the option of reversal.

“To achieve these goals, a novel male contraceptive approach of Reversible Inhibition of Sperm under Guidance (RISUG) has been developed, which has the potential to become for mass use as once injectable and reversible male contraceptive method. Significant features of this method include localized injection and no detectable interaction with other body parts unlike the hormonal injectable contraceptives,” the study said.

source/content: newindianexpress.com (headline edited)

NATIONAL: HEALTH & MEDICAL SCIENCES: National Drugs Regulator Approves Mylab’s PathoDetect™ kit, making it India’s First Indigenous Tuberculosis (TB) Detection Testing Kit

TB is an infectious disease, and according to the government data, India reported 1.93 million new TB cases in 2021.

India’s national drugs regulator has approved Pune based Mylab’s test kit to detect tuberculosis (TB) , making it the first made in India test kit to be approved for TB diagnosis, the company announced on Tuesday.

The kit simultaneously detects drug resistance to the two most commonly used drugs in TB treatment— Rifampicin and Isoniazid, the company added.

TB is an infectious disease, and according to the government data, India reported 1.93 million new TB cases in 2021, making it one of the major public health concerns in the country. India currently uses imported test kits; most of them come from US and Europe.

Apart from the central drugs standard control organization (CDSCO), the kit has also received approval from the national TB expert committee and the Indian Council of Medical Research (ICMR).

“We are addressing several problems simultaneously here. First being able to speed up testing by automated systems that can do multiple tests at one time. Secondly, there is scarce trained manpower for RT-PCR testing, which India can now overcome with fully automated system which does not need highly technical person to handle samples and reagents,” said Hasmukh Rawal, managing director, Mylab.

According to people familiar with the matter, this kit is more automated that others in the market and reduces the need for high expertise to run the test. Also, the kit can be stored at Indian room temperature; thus catering to look temperature requirements.

The kit is priced around ₹650 per unit, which is almost comparable to the prices of others in the market.

“We have technology to detect TB and drug resistance in the form of genexpert that’s a cartridge based nucleic acid amplification test. But this is an expensive test in the private sector and the advantage of made-in-India kit will be its low cost. We will still have to be sure how reliable the technology is,” said Dr Vikas Maurya, director, department of Pulmonology, Fortis Healthcare.

According to the company, the kit has been approved after rigorous and large scale field trials and recommended by TB Expert Committee under the aegis of ICMR. Multicentre centre evaluation study and field feasibility testing studies were also carried out for the test kit.

Emphasizing on the important point of drug resistance, Rawal said, “There is a huge problem of resistance to drugs when it comes to TB.

Until now, India had to conduct 2 tests: one to detect TB first and to check drug resistance – that against only one drug (Rifampicin). With Mylab’s PathoDetect™ kit, in a single test – patients can know their active TB infection as well as drug resistance to 2 most common drugs – Isoniazid and Rifampacin – so that they take treatment that will actually work. This is a milestone moment in India’s TB Testing.”

The test kits have been designed to work in ambient temperatures compared to existing PCR options which need 2-8 degree cold storage. Mylab Compact device systems do not require special infrastructure for operations and feasibility studies done on mobile van in rural areas indicate them to be very robust, said the company.

sources/content: hindustantimes.com (headline edited)