Problems of enforcements of regulations on pharmaceutical industry in Bangladesh

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Abdullah Al Faruque

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The pharmaceutical sector is highly developed in Bangladesh and contributes significantly to the country?s economy. After the promulgation of Drug Control Ordinance-1982, the development of the sector was accelerated. The professional knowledge and innovative conceptual skills played a vital role in the development of the sector as a whole. The Bangladesh pharmaceutical sector has an opportunity to establish itself as a high volume export-oriented industry close to RMG sector. In order to keep up this pace, proper regulation must be in place to control quality of the products. The main regulation to deal with this industry is the Drug (Control) Ordinance-1982. Two organizations regulate drugs and pharmacies in Bangladesh, one governmental, The Directorate General of Drug Administration (DGDA) and one semi-government, the Pharmacy Council of Bangladesh(PCB). DGDA is the drug regulatory authority of Bangladesh, which is under the Ministry of Health and Family Welfare. DGDA regulates all activities related to import and export of raw materials, packaging materials, production, sale, pricing, licensing, registration, etc. of all kinds of medicine including those of Ayurvedic, Unani, Herbal and Homoeopathic systems. PCB was established under the Pharmacy Ordinance in 1976 in order to control pharmacy practice in Bangladesh. The National Drug Policy (2005) states that the WHO?s current Good Manufacturing Practices (GMP) should be strictly followed and that manufacturing units will be regularly inspected by the DDA. Other key features of regulation are restrictions on imported drugs; a ban on the production in Bangladesh of around 1,700 drugs which are considered non-essential or harmful; and strict price controls, affecting some 117 principal medicines. The main objective of this presentation is to analyze existing laws on pharmaceutical industry and enforcement mechanisms of these laws. This study aims to identify the major problems of enforcement of the laws and policies on the pharmaceutical sector and proposes strategies to overcome these problems.

Biography :

Abdullah Al Faruque completed LLB (Hons.) and LLM degree from University of Dhaka, Bangladesh and obtained PhD degree from University of Dundee, UK in 2005. Currently he is working as a Professor and Dean, Faculty of Law, University of Chittagong, Bangladesh. He has published four books and numerous articles in reputed law journals.