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An IT System for Online Submission of Clinical Trial Application & Monitoring
An IT enabled system has been launched by the Central Drugs Standard Control Organization (CDSCO) for the online submissions of the applications for clinical trials and its monitoring. The CDSCO is the regulatory body of India responsible for thee registration of medical devices, drugs, IVDs and cosmetics. The previous blog
Stem Cell Research in India – A Step Forward
By 2017, the stem cell market in India is estimated to worth $600 million and the Government of India is focusing on to become a global leader in stem cells research and therapy. The stem cells research is saving patient lives in India. India has nine major stem cells research
Find Out Which Proposed Amendment Was Turned Down
As the Indian Healthcare Sector is witnessing a number of changes for the betterment of patient safety. An amendment of Rule 3-A of the Drugs & Cosmetics Rules, 1945 by Union Health Ministry was turned down by the Drugs Technical Advisory Board (DTAB). The proposal was to announce National Institute of
Import of Cosmetics in India – Expected Amendments
To make things simple for the registration of cosmetics imported into the country, rule 129, 129H, 135A and 145D of the Drugs and Cosmetics Rules are to be amended by the Union Health Ministry of India. You could have an overview of medical device registration in our blog section under
DDC Bengaluru Authorized to Issue NoC’s for Drug Exports
The Central Drugs Standard Control Organization (CDSCO) delegates deputy drug controller (DDC), sub zone, Shanthy Sunashekaran to issue NoC’s for the Karnataka manufacturers of unapproved / approved new drugs / banned drugs for exports. Before the manufactures has to travel Chennai to obtain the NoC for manufacturing the mentioned drugs
Growth of Medical Technology Sector in India
As a development of the “Make in India” campaign, the Central government of India is planning for a slew of policies to push the growth of medical technology sector. Evolution in regulation of the medical products, separate legislation, overhauling tax structure for domestic manufacturing said Dr VK Subburaj, secretary, department
India says Goodbye to Maternal and Neonatal Tetanus
India eliminated Maternal and Neonatal Tetanus (MNT) addressed Prime Minster Narendra Modi in a Call to Action Submit, 2015. Representatives of 24 nations attended the conference and the Prime Minister of India, said “I am happy to share with you today another major milestone achieved by India. India has eliminated
An End to Repeat Animal Testing
South East Asian countries including India, Philippines, Thailand, Malaysia, Singapore, Indonesia, Vietnam are currently in the process of developing standards for the regulatory approval processes for medical devices, drugs and cosmetics. The Indian medical device and drugs regulatory approval body has made a decision to stop repeat animal testing to
How Much Can an Accounting Error Cost?
To correct the incorrect financial statements, an Austin based medical device manufacturer estimates the cost as $28 million. In the third party accounting costs the company incurred $ 16 million in the recent SEC filing and it will spend another $12 million to correct the quarterly statements for the years
CDSCO to Maintain Inventory for Veterinary Medicines
There has been a standard regulation in practice for the medicines used for human but there are no strict measures for the usage of veterinary medicines. READ ALSO: Standard regulation of medical devices in India, Achievements of the CDSCO (Regulatory Body of India) 2014. As a result, the veterinarians says there is misuse