Pharmaceutical quality

                -  Ganadhish Kamat In an era where medicine is increasingly driven by molecular biology, randomized trials, and real-world evidence, the enduring popularity of homeopathy and the encouragement by Indian government presents a curious paradox. Born in the late 18th century through the ideas of Samuel Hahnemann, homeopathy was, in many ways, a reaction to the excesses and crude practices of early medicine. Bloodletting, toxic concoctions, and untested remedies dominated the landscape—often doing more harm than good. In that context, Hahnemann’s skepticism toward prevailing practices was not only understandable but arguably justified. But skepticism alone does not make a system scientific. Hahnemann’s central doctrine—“Similia Similibus Curentur” or “like cures like”—emerged from a self-experiment involving cinchona bark. While translating a text by William Cullen, he noted the claim that cinchona could treat malaria. After ...

                                - Ganadhish Kamat India’s Drug Law Reform: Still Stuck in 1940 India’s Drugs and Cosmetics Act was written for a country that no longer exists. In 1940, India had no meaningful pharmaceutical industry and depended heavily on imports—hence an entire chapter in the law devoted to imported drugs. Eighty-five years later, India is the “pharmacy of the world,” yet continues to be governed by a legal framework designed for colonial-era realities. Yes, amendments have been made. But amendments are not transformation. The skeleton of the law remains unchanged—and increasingly unfit for purpose. To its credit, the Ministry of Health and Family Welfare (MoHFW) recognized this in 2016 and sought industry inputs to overhaul the system. Indian pharmaceutical professionals routinely engage with global regulators like the US Food and Drug Administration an...

                              - Ganadhish Kamat India’s recent caution by the Central Drugs Standard Control Organization (CDSCO) against indirect promotion of weight-loss drugs—particularly GLP-1 analogues—has reopened an important policy debate: where should regulators draw the line between unethical drug promotion and legitimate public health communication? At first glance, the concern is understandable. India’s Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 was designed to protect citizens from misleading claims and exploitative marketing, especially for conditions like obesity, diabetes, cancer, and neurological disorders. The spirit of the law is clear—prevent commercialization of hope. However, conflating disease awareness campaigns with drug advertising risks undermining an equally important public health objective: informed citizens. Awareness is not Advertising A ...

                                                                                                                                                            - Ganadhish Kamat India’s pharmaceutical industry proudly calls itself the “pharmacy of the world.” From antiretroviral medicines to affordable generics, the country supplies drugs to more than 200 nations. Yet this reputation ultimately rests on one crucial pillar: the credibility of India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO). Recent propos...

- Ganadhish Kamat Introduction India is considered as the Pharmacy of the world and supplies high quality medicines to countries world over. While Indian drug manufacturers are capable of supplying high quality medicines at low price, can all the medicines available in India be considered to be of same quality? First of all, how do you define the quality of medicines?  Applying simple definition of Quality, "Fit for the purpose", a good quality medicine should produce desired effect after administration (Efficacy) without producing any undesired & harmful effect (Safety). Incase of products such as apparels, footwear, consumer products, food articles, electronics etc, consumers can judge the quality themselves based on sensory evaluation or evaluation of performance by actual use. If they are not happy with the quality, they have choice of not buying the product again or even sometimes returning it. This however is not possible for consumers of medicines (patients). Excep...