Pharmaceutical quality

                          - Ganadhish Kamat India’s medical landscape is uniquely pluralistic. Alongside modern evidence-based medicine, systems like Siddha and Unani continue to enjoy state patronage, institutional backing, and widespread public trust. Their cultural and historical significance is undeniable. But when evaluated through the lens of modern science, both Siddha and Unani reveal a fundamental problem: they are built on frameworks that fail basic standards of scientific validity, reproducibility, and safety. Siddha System of Medicine Siddha is one of the oldest traditional medical systems, believed to have originated in South India, especially Tamil culture. It is attributed to ancient sages called Siddhars . This system is prevelant in Tamilnadu, parts of Keralam and Srilanka. Like Ayurveda, Siddha is also Based on three humors (Mukkuttram) :  Vatham (air + movement),  Pitham (fire + m...

                -  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...