Honourable regulators, legal advisors and manufacturers please justify as why stability is mandatory to get product permission whether old drug or a new drug. Sharing facts and asking questions as why it so happening into the pharmaceutical industry over and again. Drug and Cosmetic Act is in place to regulate the pharmaceutical industry then why everyday new circular is coming to the industry people. Let the business community concentrate on business generation and business development then only country will get handsome tax amount to run the everyday show. If business community will get everyday warning letter then our gross domestic product will go down and down.

                Industry does not want everyday circular and policy change and due to that industry is losing business and commitment both in domestic market and international market. Try to understand the kind of investment requires getting the business for export and investment require to register single product. Meet and ask annual budget of Pharmexcil (Pharma Export Promotion Council of Government of India) they are investing to generate business.

                 Directly pharmaceutical industry employs approximately 5 million people and indirectly 1 million people world over. Fortunately, regulators are very sincere and working hard to take care industry as a facilitator but sometime they become autocratic in approach. We should not forget in last 10 years most of companies went to court for justice, it may be a case of fixed dose combination or price fixation.

                 Frequent policy change in Indian market really affect whole world because India is pharmacy of the world. Indian Pharmaceutical Industry is a lifeline for global citizen. Indian pharmaceutical industry supply medicine 20% of global demand. Daily basis circular or frequent policy changes are seriously not acceptable to the industry. We have to guide and nurture manufacturers like a mother and control like a father. FIR is not the solution, financial punishment is better option. Through seminars, conferences interaction with the industry and regulators are very important and this opportunity helps to resolve many untouched issues. On the other hand many regulators are guiding industry people and making feel of easy of business. 

                  Are frequent policy change increasing unemployment which is right now 7.2% Noteworthy, alone pharmaceutical Industry is the 3rd largest earner of foreign exchange. If we will work together in association with industry then we could be the largest earner of foreign exchange. We all have to resolve unwanted issue because country is going to lose the business. Please share your suggestion and guidance so that we can approach to higher authority for early resolution.

Mohammad Shahbaz Alam