A dedicated two-week training programme for drug regulatory officials from African countries has commenced at NIPER-SAS Nagar. The specialized training programme on drug regulatory affairs that was kicked off on April 10 will conclude on April 20, 2018. A total of 40 participants from 17 African countries including Botswana, Cabo Verde, Egypt, Eritrea, Ethiopia, Gambia, Kenya, Liberia, Malawi, Mozambique, Nigeria, Senegal, Seychelles, Sudan, Tanzania, Zambia, and Zimbabwe with background of drug regulatory, pharmacist and quality control/quality assurance, are attending this programme.
 
Prof R K Kohli, Vice Chancellor, Central University of Punjab, Bathinda, inaugurated the programme along with Prof Raghuram Akkinepally, Director of Punjab University. The programme is sponsored by India Africa Forum Summit Program-III (IAFS-III), Eastern and Southern Africa Division, Ministry of External Affairs, Government of India. Visits to regional drug testing laboratory, Chandigarh and two pharma manufacturing plants in Baddi are also part of this specialized training program.
 
Prof. Sanjay Jachak, the course coordinator, stated that the main objective was to train regulatory officials from African countries and to update them on the ever changing requirements of drug regulation at the same time challenges faced during implementing safety, efficacy and quality.
 
Further the course will include recent developments and implementation of pharmaceutical quality by design (QbD) for pharmaceutics. Most of the participants are drug regulatory and pharmacists in their countries. About 15 resource persons from the Indian Drug Regulatory Agencies like DCGI, CDSCO, State Drug Licensing Authority, pharmaceutical industry and academia will deliver lectures and participate in the deliberations.
 
About 4 sessions will be held on hands-on-training on different analytical instruments at the central instrumentation laboratory of NIPER. Some of the topics that will be discussed and deliberated will be investigation procedures, detection of spurious drugs and case studies, legal aspects of regulatory working, quality risk management, role of drug testing laboratory for ensuring quality medicines, regulatory aspects of herbal drug products and application of QbD to herbals. Risk-based approach – GMP, quality approach of 21st century, solid state pharmaceutics, regulatory mechanism in quality monitoring in India and restrictions on promotion by advertisements of drugs in India will be covered during the training program.
 
The participants have already visited various departments of the NIPER including Medicinal Chemistry, Natural Products, Pharmaceutical Analysis, Pharmacology & Toxicology, Pharmaceutical Technology, Pharmaceutics and Biotechnology, etc. The first two lectures were delivered by Rajendra Harna, former Drugs Controller of Haryana on the topic ‘Investigation procedures detection of spurious drugs and case studies and on ‘Legal aspects of regulatory working.’