Good Manufacturing Practices under Schedule M of the Drugs and Cosmetics Act are going to be a reality in Indian pharmaceutical industry in a few months from now. And that will mark the beginning of a new era in this industry. Implementation of GMP in pharmaceutical industry seeks to provide quality pharmaceutical products to the market through adoption of a set of minimum standard manufacturing procedures by all units in the country. There is hardly any uniformity in quality of pharmaceutical products available in the domestic market today. It is high time, therefore, the government should have introduced this manufacturing reform in this industry. As the adoption of GMP is going to be a fait accompli now, a large number of tiny and small-scale units may not remain in business after the expiry of the current deadline of December 2003. Existence of too many small drug units with little contribution to the quality pharmaceutical production has been causing serious administrative problems for the state regulatory authorities. One of the main reasons for the increasing circulation of spurious drugs in the country is the inefficiency of state drug administrations caused by utilization of the available resources to manage these huge number of drug units.
If the benefit of quality pharmaceutical products has to reach the ultimate consumer, the trade too has to play a crucial role. But, the regulatory compliance by pharmaceutical trade and monitoring by the drug authorities are extremely poor in this country despite certain provisions in the D&C Act. Flouting of rules start from the factories when drugs and pharmaceuticals are lifted for sending to various destinations. Barring vaccines and expensive injections, most of the drugs and pharmaceuticals are transported in open trucks exposing them to frequent temperature variations. One can very well imagine what will be potency and shelf life of medications if they are in transit in such adverse conditions for weeks. The medicines are then stored in retail shops without maintaining the prescribed temperature conditions. In summer months, medicines are thus kept above 40 degree centigrade in most parts of the country. If this is the way the pharma trade is going to be run from January 2004 the whole implementation of Schedule M has little meaning. Running of chemists' shops without registered pharmacists and promotion of generic drugs at huge margins in collusion with pharma companies are some of the other unfair practices widely prevalent in this trade. It is heartening to note, in this context, that at least officials like Venkata Reddy from AP Drug Control Administrations has taken the initiative to introduce good trade practices in the state without any enabling provision like Schedule M in the D&C Act. The AP DCA is insisting on air conditioning for getting licenses to open new retail shops, presence of registered pharmacists wearing white aprons, earmarking a separate space for date expired medicines, etc. A Central legislation is called for to define and enforce good trade practices in this sector if other state governments are not adopting the Andhra model.