The government of India has made it mandatory to bar-code mono cartons (primary packs) of drugs shipped out of the country from July 1 2015. Primary packaging includes ampoules, vials, bottles, cartridges and blister-packs. This is to ensure that the reputation of the Indian pharma industry is not tarnished by medicines manufactured illicitly in other…

In December 2014, the Union Health Ministry of India decided to set up a high level committee to review the Drugs and Cosmetics Act 1945 and make the rules more relevant. The committee has now set up 7 sub-groups to look at different segments. The following 2 groups are relevant for Medical Devices:   1….

Dr. Arun Bal is one of the most prominent diabetologists in India. He is a diabetic foot surgeon at Raheja Hospital, Mumbai. He is also the President of Diabetic Foot Society of India. The following Q&A dates back to 2007; however the issues addressed are equally relevant today.   Q I am a 55 year-old…

What is it The government of India plans to sell generic medicines at low prices under the “Jan Aushadhi” brand. Already, there are more than a 100 Jan Aushadhi outlets set up at District Hospitals since the program was started in 2008. Making the brand available in regular pharmacies will greatly increase the reach of…

A team at the Ecole Polytechnique Federale in Lausanne, Switzerland has announced the development of flexible spinal implants that could help paralysed people walk again. The implant is called the eDura for “electronic dura mater”. The dura mater is the soft connective tissue that surrounds the brain and spinal cord. Traditional implants are more rigid…

The  Antimicrobial Discovery Center at Northeastern University in Boston, US announced the discovery of Teixobactin, the first new class of antibiotics in nearly 30 years.  The discovery is a breakthrough because bacteria are increasingly becoming resistant to existing antibiotics. The rampant misuse and overuse of antibiotics has been blamed for this increasing bacterial resistance. Also, pharmaceutical companies had…

Today, the Indian Cabinet has approved 100% FDI in Medical Devices in India. Till now, FDI (Foreign Direct Investment) in this sector required FIPB (Foreign Investment Promotion Board) approval. The need for FIPB approval led to long delays in getting foreign funding. The definition of a Medical Device is broad and includes  “instrument, apparatus, appliance, implant, reagent,…