Largest ever drug survey in the world
22-Feb-2017: Health Ministry undertakes largest ever drug survey in the world for determining the quality of drugs
The Ministry of Health and Family Welfare, Government of India had entrusted the work relating to carrying out a Survey of the extent of Problems of ‘Spurious and Not of Standard Quality Drugs’ to the National Institute of Biologicals (NIB), Noida. The NIB has since submitted the report to the Government.
The statistical design of the Drug Survey included as many as 224 Drug molecules belonging to 15 different therapeutic categories of the National List of Essential Medicines (NLEM) 2011. As part of this survey, 47,954 drug samples relating to 23 dosage forms were drawn from 654 districts of 36 States and Union Territories from the supply chains including retail outlets, Government sources and from eight airports and sea ports.
A nationwide training in drugs survey methodology was imparted at 28 centres across the country to over 1800 Sample Drawing Officers (SDOs) and representatives of the Civil Society / Pharmacy Council of India (PCI). The role of the Civil Society / Pharmacy Council of India (PCI) representatives was to observe that the drugs samples are drawn in accordance with the sampling methodology and the highest degree of transparency and objectivity is maintained in the process to eliminate any bias.
All the samples were subjected to test / analysis as per pharmacopoeia requirements in the Central and State Drug Testing Laboratories that have been accredited by NABL. Overall, out of the 47,012 samples tested, 13 samples were found to be Spurious and 1,850 samples were found to be ‘Not of Standard Quality’ (NSQ). As such, the percentage of NSQ Drugs in India has been found to be 3.16% and that of Spurious drugs 0.0245%.
This is the largest ever scientifically designed and professionally executed drug survey undertaken in the world for determining the quality of drugs.
Medical Devices Rules
2-Feb-2017: Health Ministry Notifies Medical Devices Rules, 2017
The Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices. Only 15 categories of medical devices are, at present, regulated as drugs and to that extent, the current regulatory practices in India were not fully geared to meet the requirements of medical devices sector in the country. The new Rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
Medical devices will, under the new Rules, be classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.
GM Mosquito
25-Jan-2017: GM Mosquito to control Aedes aegypti
Outdoor caged trials to demonstrate the efficiency of genetically modified mosquitoes to suppress wild female Aedes aegypti mosquito populations that transmit dengue, chikungunya and Zika were launched on January 23 in Maharashtra.
Based on the results of the trials, which use the Release of Insects carrying Dominant Lethal genes (RIDL) technology, and permission from Indian regulatory authorities, Gangabishan Bhikulal Investment and Trading Limited (GBIT) and Oxitec, plan to conduct open field trials in the country.
Laboratory-based studies have already been carried out in India since 2012 by GBIT and Oxitec and these studies have demonstrated the compatibility of Aedes aegypti mosquitoes.
The efficiency to kill offspring was over 99% and male mosquitoes imported from the U.K were able to mate with locally available wild female mosquitoes and the longevity of imported mosquitoes was the same as the wild ones.
Modified males
Oxitec’s technology uses genetically modified male Aedes aegypti mosquitoes that carry a dominant lethal gene. When male GM mosquitoes mate with wild female mosquitoes the lethal gene is passed on to offspring. The lethal gene in the offspring kills the larvae before they reach adulthood.
Since male mosquitoes do not bite humans, the release of GM males will not increase the risk of dengue, chikungunya and Zika.
The caged trials will last 50-55 weeks. Surveillance to gather data on predominance of Aedes mosquitoes in the wild has already started. The open field studies will be conducted for about a year in two villages in Jalna.”
It is a promising technology and India must certainly look at new vector control methods. From studies carried out in other countries we know the safety is beyond doubt, but efficiency has to be proved, especially in big cities and towns.
Practical considerations
There are practical problems of raising a large number of mosquitoes needed for vector control – 100-150 [GM] mosquitoes are needed per person for months together. Large numbers of GM male mosquitoes have to be released at regular intervals to compete with wild normal males for mating. Since the larvae die before reaching adulthood, the technology is a “self-limiting approach”.
India is looking at another alternative. We are about to sign a memorandum of understanding next month with Monash University for vector control using Wolbachia-infected A. aegypti mosquitoes. Vector control using A. aegypti infected with the bacterium Wolbachia is achieved by using the life-shortening bacteria strain in both male and female mosquitoes. Uninfected wild female mosquito embryos fertilized by Wolbachia-infected males fail to develop, while embryos from infected females fertilized by infected or uninfected wild males survive. As Wolbachia is maternally inherited, the bacteria are anyway passed on to offspring. Dengue, Zika or chikungunya viruses cannot replicate when mosquitoes have Wolbachia. Unlike the RIDL technology, a feature of Wolbachia is that it is self-sustaining, making it a low-cost intervention.
The downside is that the release of even a single female mosquito infected with Wolbachia could “potentially lead to the alien bacteria spreading in the target population,” says a June 2013 report in Pathogens and Global Health.