Clinical Trials Registry – India (CTRI)

• Clinical Trials Registry – India (CTRI) is the government of India's official clinical trial registry.
• The National Institute of Medical Statistics of the Indian Council of Medical Research established the CTRI on 20 July 2007.
• Since 2009 the Central Drugs Standard Control Organization has mandated that anyone conducting clinical trials in India must preregister before enrolling any research participants.
• The CTRI requests all the information which the World Health Organization recommends for clinical trial registries.
• Additionally, the CTRI collects information specific to the circumstances of India, including

1. the address of the principal investigator,
2. the name of the ethics committee overseeing the trial and confirmation of their government registration;
3. proof of permission from the Drugs Controller General of India, the expected end date of the trial;
4. all study sites; and
5. the method of randomizing participants and the allocation concealment.

• The World Health Organization Registry for clinical trials helped make the Indian registry more effective.

Ayurveda Dataset on CTRI Portal

• Marking a significant step towards worldwide visibility for Ayurveda based clinical trials, the Ayurveda dataset on CTRI Portal will be launched online tomorrow by Ayush Minister Shri Kiren Rijiju.
• This Ayurveda Dataset of CTRI has been jointly developed by ICMR and CCRAS, Ministry of Ayush.
• The Minister will also launch four more Portals, all developed by the Central Council for Research in Ayurvedic Sciences (CCRAS).
• CTRI is a primary register of Clinical Trials under WHO’s International Clinical Trials Registry Platform (ICTRP) and creation of Ayurveda dataset in CTRI facilitates usages of Ayurveda terminologies to record clinical study meta data based on Ayurveda interventions. Until now the clinical trials in Ayurveda were dependent on terminology borrowed from modern medicine.
• The key feature of this digital platform is the provision of selection of the Ayurveda Health conditions from drop down of 3866 Ayurveda morbidity codes incorporated from the NAMASTE portal (a portal developed by the AYUSH Ministry) in which morbidity statistics pertaining to Ayurveda has been classified according to International Classification of Diseases standards.
• It means, now the information, results etc. of Ayurveda Clinical Trials will be available in Ayurvedic vocabulary in the clinical trials registry of India.

Why is the Clinical Registry important?

• Clinical trials are being done continuously in the world for new drug discovery, treatment of diseases etc.
• The problem is that the results of these tests are not publicly available and due to this there is a possibility of not having accurate information about the trials.
• In view of this, the World Health Organization made it mandatory to create an online registry of clinical trials.
• In India this work is being done through CTRI and this registry is also part of the World Health Organization registry.
• The four more portals that will also be launched tomorrow are AMAR, SAHI, e-MEDHA and RMIS. All of these are primarily developed by CCRAS while RMIS is a collaborative effort of ICMR and CCRAS.

Crocodile species in India

There are 3 species of crocodilians in India —

1. Saltwater/ Estuarine Crocodile;
2. Mugger/ Marsh/ Indian/ Broad snouted Crocodile and
3. Gharial or Gavial or Fish eating crocodile

Mugger Crocodile or Marsh Crocodile or Broad snouted crocodile

1. It is mainly a freshwater species, and found in lakes, rivers and marshes.
2. It is Vulnerable in IUCN; Appendix I of CITES; Schedule I of WPA.
3. Its habitat includes wetlands (inland), marine neritic (shallow part of the ocean), artificial/aquatic & marine. Vadodara is the only city in India where crocodiles live in their natural habitat amidst the human population.
4. It is extinct in Myanmar and Bhutan and possibly extinct in Bangladesh.
5. Recently Gujarat relocated Mugger crocodile from Sardar Sarovar dam to facilitate sea plane service at Statue of Unity.
6. The mugger population is increasing in Odisha's Ghodahada reservoir.

Gharial or Gavial or Fish eating crocodile

1. It is native to the Indian subcontinent. It is Critically Endangered by IUCN; Schedule I of WPA.
2. The male gharial has an earthenware pot-like structure at the snout.
3. Gharial once inhabited all major river systems of the Indian Subcontinent, from the Irrawaddy River in the east to the Indus River in the west. Their distribution is now limited to only 2% of their former range.
   1. India: Girwa River, Chambal River, Ken River, Son River, Mahanadi River, Ramganga River.
   2. Nepal: Rapti-Narayani River
4. Sites: National Chambal Sanctuary, Katarniaghat WS, Son River Sanctuary and the rainforest biome of Mahanadi in Satkosia Gorge Sanctuary, Orissa.
5. Threats: Hunting for skins, trophies and indigenous medicine, and their eggs collected for consumption, Decrease of riverine habitat as dams, barrages, irrigation canals and artificial embankments were built; siltation and sand-mining changed river courses.

Saltwater Crocodile

• It is the largest of all living reptiles.
• It is listed as the least concern by IUCN.
• It is found throughout the east coast of India.

Conservation Efforts

• Project Crocodile: (Gharial + SW, then Mugger added)
  1. Started in 1975 with the help of UNDP and FAO. Initially for Gharial and Saltwater crocodile and then Mugger was added.
  2. This includes a captive breeding programme and the involvement of the local community in conservation.
  3. Started in Odisha 1st as it has all 3 species of crocodiles.
• Crocodile Census by Odisha
  1. The population of Saltwater crocodiles increased in Odisha's Bhitarkanika NP and in Kendrapara.
  2. The increase in population was primarily due to the far-sighted measures of the government.
• ‘BAULA’ Project AT Dangamal in Bhitarkanika Sanctuary for Saltwater Crocodile.
• MUGGER Project at Ramatirtha in Odisha.
• Gharial Project at Tikrapara, Odisha. Odisha renews effort to revive Gharial (or Gavial or Fish Eating Crocodile) Population.
• Captive Breeding of crocodiles at Nandankanan, Odisha.