Pharmaceutical quality

  - Ganadhish Kamat In the current times Pharmaceutical industry is facing lot of challenges. These include – Pricing pressure due to various initiatives by governments to control healthcare cost in the respective countries & consolidation of buyers in US. Large number of generic approvals even for complex generics on day 1 in US thereby not giving huge dividends for being first to market the generic version. High cost of development, high investments & long gestation period for complex generics. Increased regulatory expectations & scrutiny. Increasing costs due to rise cost of materials, transportation, energy, wages etc. Only way the industry can overcome these issues and come out winner is by adopting philosophy of continuous improvement. Continuous improvement will help in improving efficiency, productivity, yields, resource utilization etc and help driving down the cost. It will also help in making

                                                           -            Ganadhish Kamat Introduction - CDSCO had issued Draft Schedule M vide GSR 999(E) in 2018 for inviting comments from the stakeholders. Since the Schedule was getting revised after 17 years, I personally went through the entire document and provided exhaustive comments to CDSCO as individual as well as through the company I was working with and through IPA. I am sure many others also must have painfully gone through the documents and provided comments in view of making the document better and as scientific and flawless as possible. When draft is published for comments, it is fair to expect that, comments received will be collated and evaluated and if found logical incorporated into final document. Even a workshop with the stakeholders could have been good idea to better understand logic behind the suggestions / comments and to resolve any doubts. Unfortunately, this process was not followed by the agency which expe

The government of India has created ministry for AYUSH for active promotion of ancient therapies such as Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa and Homeopathy. Government has also set up All India Institute of Ayurveda in Delhi and Goa to promote research in Ayurveda and offer PG & PhD programs while providing Ayurvedic treatment. Encouraged by these government initiatives, many companies like Patanjali have launched many Ayurvedic products and advertise them in newspapers and other media claiming treatments for various diseases in violation of " Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954."  Many of the advertised medicines contain common herbs and claim to permanently cure diseases like BP, Diabetes, heart ailments, asthma, thyroid, infertility and even cancers. With my Pharmacy background, I found these claims to be outlandish and unscientific. However before coming to conclusion, I decided to read one of the main books "