The Central Drugs Standard Control Organisation (CDSCO) has approved 67 Ethics Committees in Karnataka. These ethics committees are from large and small hospitals in the state. The re-registration is mandated under the amendments to Drugs and Cosmetics Rules published vide G.S.R. dated 08.02.2013. It specifies the requirements and guidelines for registration of Ethics Committees and re-registration under Rule 122DD to the Drugs and Cosmetics Rules 1945.
 
CDSCO has since registered several Ethics Committees. The registration of Ethics Committees is valid for a period of three years. The re-registration applications need to be made within 3 months before the expiry of registration. Registration remains deemed continued unless otherwise orders are passed or until the registration is suspended or cancelled, stated the regulatory authority.

For that reason, applicants should apply to CDSCO for re-registration as per the check list. If there is no change in address, composition etc. only such undertakings along with details of performance of Ethics Committee with respect to its review and monitoring function needs to be provided.
 
The regulatory authority further stated that the procedure is kept quite simple to facilitate re-registration. Check-list along with a covering letter and necessary documents need to be submitted. The documents with page numbering must be in clear and legible language, ensuring sufficient margins space for easy handling, evaluation, storage and retrieval.
 
From Karnataka around 70 Ethics Committees submitted their re-registration details following the notification. These include JSS Medical College and Hospital Mysuru, KLE University, JN Medical College, Belagavi, M. S Ramaiah Medical College and Hospitals Bengaluru, IECCS of Apollo Hospitals, Bengaluru, Apollo BGS Hospitals, Mysuru, Omega Hospital, Mangaluru, Diacon Hospital Diabetes Care and Research Centre, Bengaluru, Indira Gandhi Institute of Child Health Bengaluru, Karnataka Institute of Medical Sciences Hubballi, A J Institute of Medical Sciences and Research Centre, Mangaluru, Sushruta Multi speciality Hospital and Research Centre Hubballi, St. John's Medical College, Bengaluru, Sri Siddhartha Medical College Tumkuru, Life Care Hospital Bengaluru, Rajarajeshwari Medical College and Hospital Bengaluru, NIMHANS, Bengaluru, Narayana Nethralaya Bengaluru, Sri Devaraj Urs Academy of Higher Education and Research Kolar, Sapthagiri Institute of Medical Sciences and Research Centre, Bengaluru, Shri B.M Patil Medical College Hospital and Research Centre, Vijapura, Manipal University, Manipal, BGS Global Hospitals, Bengaluru, Ace Independent Ethics Committee Bengaluru, Baptist Hospital Bengaluru, Kasturba Hospital, Manipal Mandya Institute of Medical Sciences District Hospital Mandya, Mysore Medical College and Research Institute and Associated Hospitals Department of Pathology, Mysuru, Sri Venkateshwar Hospital, Bengaluru, Kempegowda Institute of medical Sciences, Bengaluru, Gurushree Hi-tech Multi Speciality Hospital Bengaluru, Sri Jayadeva Institute of Cardiovascular Sciences and Research Bengaluru, Pristine Hospital and Research Center Bengaluru, Fortis Hospital, Bengaluru, Dr. B.R Ambedkar Medical College Bengaluru, Nanjappa's Life Care Shivamogga, Father Muller Medical College Mangaluru, Bhagwan Mahaveer Jain Hospital Bengaluru, Manipal Hospital Bengaluru, Medisys Clinisearch India Bangalore Diabetes Centre Bengaluru, Rangadore Memorial Hospital Bengaluru, HCG Bangalore Institute of Oncology Bengaluru, Mangala Hospital and Mangala Kidney Foundation Bengaluru, Public Health Research Institute of India Mysuru, Narayana Hrudayalaya Bengaluru, Belgaum Diabetes Centre Belgaum, Bangalore Medical College and Research Institute, Bengaluru and Columbia Asia Referral Hospital, Bengaluru.
 
According to the regulations, all ethics committees will need to adhere to the schedule Y norms and good clinical practice guidelines. The inspectors of CSDCO will also need to be permitted entry into the premises of these registered facility at any point of time.