PHARMA LITERATI

The National Accreditation Board for Hospitals and Healthcare Providers (NABH) will be conducting a series of workshops on ethics committee (EC) accreditation in clinical trial from May 11, 2019 to September 14, 2019 for hospitals, small healthcare organisations, allopathic clinic, ayush hospitals, dental hospitals, dental clinics and ethics committee members across 10 cities in India. The first one-day workshop will be conducted in Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), ICMR, Patna on May 11. This will be followed by a workshop in Meditrina Institute of Medical Sciences, Nagpur; Christian Medical College and Hospital, Ludhiana; and Rhythm Heart Institute, Vadodara. This will be followed by workshops in Nashik, Bhubaneswar, Goa, Indore, Chandigarh and Jaipur. NABH is a constituent board of Quality Council of India (QCI), which establishes and operates accreditation and certification programmes for healthcare organizations. NABH h...

India has waived a requirement that pharmaceutical companies conduct local clinical trials before they’re approved for marketing in the country, if those drugs have been approved in select other countries. The move will fast-track approvals and benefit patients, India’s government says. The New Drugs and Clinical Trials Rules, released last month, allows drugs to be approved in India if they’re already approved in the US, UK, EU, Japan, or Australia. Previously, it took three to six months to get a drug approved in India. The new rules will reduce that time to one month for drugs manufactured in India and three months for those made elsewhere. The clinical trial waiver will also extend to drugs that receive marketing approval elsewhere while a trial is underway in India. The new regulation also includes provisions for compensation for clinical trial participants who suffer death, permanent disability, or injury as a result of a trial. The Indian Society for Clinical Res...