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Seperate Regulation for Medical Devices in India
A bill which is awaited to be passed in the parliament of India which would enable distinguish medical devices and drugs regulations in India. An association of medical device manufacturer, AdvaMed said there are around 14000 types of medical devices and only 22 are listed as notified medical devices in
How Many Sub-Standard Drugs in India?
The Central government of India informed the result of drug testing which they conducted in the last three years. 4.4% of drugs were found to be of substandard in India: 9092 were found to be of substandard quality out of 2,05,448 samples tested collected from 36 states. In a written reply
A New Regulatory Body for AYUSH Drugs
Lok Shabha informed, “A structured regulatory regime for AYUSH drugs is considered to be set up”. Shripad Naik, the minister of AYUSH said in written to parliament of India, “Government mulls a structured regulatory regime for AYUSH (Ayurveda, Siddha, Unani and Homoeopathy) drugs. The proposal is to have a vertical
India to Put Mechanism on Online Sale of Drugs
A subcommittee which would draft a mechanism to sale prescription drugs online says studying other countries online drug sales should also be involved in the part of the regulations for the same. The committee was formed by the Drugs Controller General of India (DCGI). Dr Harshdeep Kamble, Maharashtra Food &
Indian Regulatory Structure: What you need to know?
The Indian government’s intention for many years to oversee registration of medical devices in India with a developed regulatory structure which is still not materialized but there were a number of steps taken to move the medical device registration to a substantial one. To look after the growing medical device
Another Hope For Indian Medical Device Industry Growth
By 2016, the Indian medical device industry is expected to grow from $ 4.4 billion to $ 7 billion addressed by a US – India business body in a government meeting. The US – India business school (USIBC) also stressed the importance of separate regulations for medical devices. READ ALSO:
WHO issues Draft Norms to Ensure High Quality of Drugs
The World Health Organization (WHO) has issued a draft of guidelines to ensure high drug quality standards in the market. Various recommendations, methodogical approaches have been provided in the draft. Comments are welcomed till 30th September 2015, and the topic will be presented in 50th WHO Expert Committee meeting held
DCGI Authorizes Zonal Officers to Grant Test Licenses
Zonal Officers gets authorization from the Drug Controller General of India (DCGI) to sign test licenses in Form 11 of the Drugs and Cosmetic Rules, 1945 which is used for importing small quantities of drugs for the purpose of conducting bioavailability/bioequivaience (BA/BE) study. On the subject, in the continuation of
NPPA says 2013 provisions are applicable to Notified Medical Devices
The clarification came from the National Pharmaceutical Pricing Authority (NPPA) that medical devices including orthopaedic implants will be in drugs category, which applies the provisions of DPCO 2013 to notified medical devices. NPPA said “Para 20 of DPCO, 2013 gives us the non-scheduled formulation monitoring. Under Drugs & Cosmetics Act
Fast Emerging Medical Devices Manufacturing and Import Hub in India
For medical and dental instruments UP is becoming an emerging manufacturing center. On the release of a study titled “Indian Medical Devices Industry: The way ahead” D.S. Rawat, national secretary general of Assocham said “By 2020, UP could emerge as manufacturing hub if tax concessions are made available for the