Drug Patent Expirations for October 2015
| Tradename | Applicant | Generic Name | Patent No. | ||||||
|---|---|---|---|---|---|---|---|---|---|
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatchdatabase for complete details.
| |||||||||
Saturday, 17 October 2015
Drug Patent Expirations for October 2015
Monday, 14 September 2015
CDSCO launches IT enabled system for online submission of applications & monitoring of clinical trials
The clinical trials on the new drugs are regulated under the provisions of the Drugs &
Cosmetic Rules, 1945, amended from time to time.
In order to improve transparency, accountability and efficiency in processing of clinical
trial applications and it’s monitoring, CDSCO with the approval of Ministry of Health and Family
Welfare, Government of India has taken initiative to create an IT enabled system for online
submission and processing of application as well as monitoring of clinical trials in the country.
In the first phase, an IT enabled system for online submission of clinical trial applications has been created and made accessible to the stakeholder through http://octams.gov.in. On trial basis, the applicants maynow upload their clinical trial applications online through http://octams.gov.infor the purpose of feedback / suggestions only.
The usual procedure of submission of application physically through hard copy shall continue till the system for online submission is made fully operational and adopted by CDSCO. The suggestions/comments, if any, may please be forwarded to CDSCO through email at dci@nic.in or phone at 011-23236965 for addressing the issues in consultation with NIC.
In the first phase, an IT enabled system for online submission of clinical trial applications has been created and made accessible to the stakeholder through http://octams.gov.in. On trial basis, the applicants maynow upload their clinical trial applications online through http://octams.gov.infor the purpose of feedback / suggestions only.
The usual procedure of submission of application physically through hard copy shall continue till the system for online submission is made fully operational and adopted by CDSCO. The suggestions/comments, if any, may please be forwarded to CDSCO through email at dci@nic.in or phone at 011-23236965 for addressing the issues in consultation with NIC.
Saturday, 5 September 2015
Drug Patent Expirations for September 2015
Drug Patent Expirations for September 2015
| Tradename | Applicant | Generic Name | Patent No. | ||||||
|---|---|---|---|---|---|---|---|---|---|
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatchdatabase for complete details.
| |||||||||
Thursday, 27 August 2015
Saturday, 15 August 2015
National Drugs Survey 2015 - Around 43,000 samples of drugs sent for testing
 |
This survey, being done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Organisation (NSSO), is a pan-India project in which drug samples were drawn from healthcare institutions and retail pharmacies across the country to assess the quality of drugs available to the common man.
According to an official, "All studies till date have been done only for spurious drugs. No 100 per cent testing for NSQ has been done till date. The new pan-India study will therefore not do any partial testing but complete testing for the first time in the history of India."
Collection of 43,000 samples has been done successfully covering all the retail drug stores including government medical stores, CHCs and PHCs as part of the pan-India survey. The exercise of pan-India drugs survey is a mammoth exercise as it covers 29 states and 7 union territories. Around 1000 drug inspectors from across the country have done sampling of drugs from retail pharmacies, CGHS dispensaries, ESI hospitals, Central Medical Stores Depots, PHCs and CHCs.
In order to facilitate effective sampling of drugs by the drugs inspectors, all the 224 molecules covering 15 therapeutic drug categories were assigned a unique sequence in the format developed through a statistical design which ensures that the drug inspector can pick up samples only on the basis of statistical design and not on their own. Around 1000 drug inspectors and an equal number of NGOs were trained to execute the sampling process to implement the study in the most meticulous and transparent manner. Around 1500 drug survey seals with unique ID numbers were also developed to be able to track the respective drug inspector with a respective assigned seal number.
The analysis and testing is facilitated through a specialised AKS software which helps in offering field data on spurious and NSQ drugs online on a consistent basis in a seamless and flawless manner.
Dr Surinder Singh, director, NIB, Noida, is the chairman of the committee conducting the survey. This broad-based survey would help in identifying the geographical areas where spurious drugs are available so that a focused monitoring is done by the concerned authorities in these areas for eliminating the menace of spurious drugs.
Earlier, a survey to assess the extent of spurious drugs in the country was conducted in the year 2009 by the ministry of health, which revealed that the extent of drugs found spurious was 0.046 per cent only.
The CDSCO formulated the survey plan in consultation with NIB for conducting a scientific study on the extent of problems of spurious drugs and drugs not of standard quality. Through this initiative between the state and the Centre, India will now be able to project a clear statistics on spurious drugs, thus clarifying the country's stand on the same with scientific evidence.
drugscontrol.org
Wednesday, 5 August 2015
Drug Patent Expirations for August 2015
Drug Patent Expirations for August 2015
| Tradename | Applicant | Generic Name | Patent No. | ||||||
|---|---|---|---|---|---|---|---|---|---|
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatchdatabase for complete details.
| |||||||||
Thursday, 23 July 2015
Drug Patent Expirations for July 2015
Drug Patent Expirations for July 2015
| Tradename | Applicant | Generic Name | Patent No. | ||||||
|---|---|---|---|---|---|---|---|---|---|
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatchdatabase for complete details.
| |||||||||
Subscribe to:
Posts (Atom)