Implementation of GMP under the amended Schedule M of the Drugs & Cosmetics Act in 2005 has been a turning point in the history of Indian pharmaceutical industry. Despite having a lot of resistance from the small scale sector, the government could notify the amendment and enforce the process of adoption of this basic manufacturing standard among the SSIs in pharma industry. Only a few hundreds of small drug units have complied with the amended provision in the Act so far and many are still in the process of adopting the norms. Whereas, a few thousands of SSIs had already closed down during the last three years. Enforcement of GMP has thus opened a new chapter in manufacturing standards in this sector. This new order in drug manufacturing was badly needed in the SSI sector as several tiny and small drug manufacturing units have been producing medicines in a dismal environment for several years. Production of drugs should necessarily have some basic facilities to ensure a minimum quality and safety standards as these products are life saving ones. There should be no compromise in this matter. SSIs have to invest for making some basic manufacturing facilities if they have to be in this business.
Often, SSIs are branded as producers of spurious and substandard drugs, cases are filed against them and are being harassed by the government officials. Certainly there are quite a few small units are indulging in such activities but that is not the case with the majority. In fact, most of the SSIs in this sector are weak with poor financial and marketing capabilities. And there has been no exclusive organization to represent the case of the SSIs until 2003 when Confederation of Indian Pharmaceutical Industries was founded. Subsequently, another body, SME Pharma Industries Confederation was also formed to represent small and medium scale units. Now both the bodies have been quite vocal about the issues facing SSI sector and they have been raising them directly and indirectly in recent months. SPIC has sent a detailed representation to the Prime Minister narrating problems of the sector and raising several demands. A Rajya Sabha MP has also taken up the cause of SSIs and shot a letter to the PM's office seeking a comprehensive policy for SSIs in the sector last week. The major grievance of the SSIs is that most of them are not getting adequate financial assistance from banks and other funding agencies for their operations. Secondly, they are not getting a due share of tender business of various government agencies and establishments. Mostly the government tenders for purchases of medicines are being cornered by large companies. These and other demands could be genuine but they have to be examined. At the same time, it is important that the government has to hear them out and come out with some supportive policy initiatives.