The book “Healing the Pharmacy of the World- An inside story of medical products manufacturing and regulation in India” by K L Sharma, formerly, Joint Secretary in the Ministry of Health and Family Welfare, Government of India is a new addition to the literature on the Indian medical products regulation and manufacturing. This is the first time ever that a book on the topic has been written by a senior bureaucrat who has handled drug regulation at the governmental level. The book published through Notion Press, Chennai highlights that the Indian pharmaceutical industry continues to be an enigma. Its mere mention evokes divergent responses from stakeholders. At one end, it is projected as the messiah of low-cost medicines that plays a dominant role in enhancing the global availability, accessibility and affordability of generic medicines. On the other end, it is ridiculed for the alleged non-compliance with good practices concerning manufacturing, clinical, laboratory, transportation, distribution and storage (GxPs) of medical products, as well as for data fudging and use of poor quality Active Pharmaceutical Ingredients. The author has highlighted how the lack of effective regulation of medical products in India could pose a serious risk to the lives of billions of consumers across the globe. The book highlights that the absence of stringent National Regulatory Authority in India puts paid to public health protection- a primary mandate of every NRA as NRA is not only responsible for the quality, safety and efficacy of drugs; they play an important role in healthcare innovation. It highlights that the diffused responsibility with overlapping jurisdictions of the central and state governments; the multiplicity of laws and agencies responsible for nurturing and regulating the sector; lack of coordination; poor human resources management; the inadequacy of resources and inefficient record management are the major problem areas. Many of these weaknesses, the author argues, can be traced to the constitutional fault-lines, archaic laws, absence of political will and commitment to reforms, half-hearted efforts at strengthening and reforming the drug regulatory architecture, bureaucratic inefficiency, poor implementation and a host of other factors. It brings out how the process of legal reforms and strengthening of regulatory structures for which a number of recommendations have been made by innumerable government-appointed committees, has not reached anywhere. The book brings out how the Fixed Dose Combinations (FDCs) that were never approved by the competent authorities continued to be marketed for decades. It highlights the results of the largest-ever drug survey 2014–16 for determining the quality of drugs involving over 47,000 samples which brings out that the ‘Not of Standard Quality’ drugs were the highest in government supplies. The book details how the risk-based inspections of a large number of pharmaceutical manufacturers brought out instances of glaring non-compliances including in respect of critical areas. The surprise inspection of wholesale distributors of pharmaceuticals in Delhi in June 2017 mentioned in the book underpin how every norm of the good storage and distribution practices had been flouted. It also highlights how the politicians and the bureaucrats have skirted decision making and, in a few cases, taken decisions that were outright irrational. It also pinpoints the inability to establish an ecosystem for nurturing of the pharmaceutical and medical devices sectors. On the positive side, it highlights how a number of manufacturing units are doing an excellent job and their facilities and compliance standards are at par with the best in the world. It has been pointed out that the repeated inspections by regulators of importing countries have led to a massive improvement in their conformance with quality parameters that have continued to be scaled up progressively. The Productivity Linked Incentive schemes relating to pharma and medtech sectors launched recently have been analyzed in detail and 121 recommendations have been made to spruce up the sectors. The book unravels many hidden secrets and presents a compelling context for the government and the Indian pharmaceutical and medtech industry to wake up and take prompt, corrective and preventive action. The book goes a long way in filling up the wide gaps in the existing literature on the subject and the findings of the regulators of countries importing medicines from India.
The book “Healing the Pharmacy of the World- An inside story of medical products manufacturing and regulation in India” by K L Sharma, formerly, Joint Secretary in the Ministry of Health and Family Welfare, Government of India is a new addition to the literature on the Indian medical products regulation and manufacturing. This is the first time ever that a book on the topic has been written by a senior bureaucrat who has handled drug regulation at the governmental level.
The book published through Notion Press, Chennai highlights that the Indian pharmaceutical industry continues to be an enigma. Its mere mention evokes divergent responses from stakeholders. At one end, it is projected as the messiah of low-cost medicines that plays a dominant role in enhancing the global availability, accessibility and affordability of generic medicines. On the other end, it is ridiculed for the alleged non-compliance with good practices concerning manufacturing, clinical, laboratory, transportation, distribution and storage (GxPs) of medical products, as well as for data fudging and use of poor quality Active Pharmaceutical Ingredients.
The author has highlighted how the lack of effective regulation of medical products in India could pose a serious risk to the lives of billions of consumers across the globe. The book highlights that the absence of stringent National Regulatory Authority in India puts paid to public health protection- a primary mandate of every NRA as NRA is not only responsible for the quality, safety and efficacy of drugs; they play an important role in healthcare innovation. It highlights that the diffused responsibility with overlapping jurisdictions of the central and state governments; the multiplicity of laws and agencies responsible for nurturing and regulating the sector; lack of coordination; poor human resources management; the inadequacy of resources and inefficient record management are the major problem areas. Many of these weaknesses, the author argues, can be traced to the constitutional fault-lines, archaic laws, absence of political will and commitment to reforms, half-hearted efforts at strengthening and reforming the drug regulatory architecture, bureaucratic inefficiency, poor implementation and a host of other factors. It brings out how the process of legal reforms and strengthening of regulatory structures for which a number of recommendations have been made by innumerable government-appointed committees, has not reached anywhere.
The book brings out how the Fixed Dose Combinations (FDCs) that were never approved by the competent authorities continued to be marketed for decades. It highlights the results of the largest-ever drug survey 2014–16 for determining the quality of drugs involving over 47,000 samples which brings out that the ‘Not of Standard Quality’ drugs were the highest in government supplies. The book details how the risk-based inspections of a large number of pharmaceutical manufacturers brought out instances of glaring non-compliances including in respect of critical areas. The surprise inspection of wholesale distributors of pharmaceuticals in Delhi in June 2017 mentioned in the book underpin how every norm of the good storage and distribution practices had been flouted. It also highlights how the politicians and the bureaucrats have skirted decision making and, in a few cases, taken decisions that were outright irrational. It also pinpoints the inability to establish an ecosystem for nurturing of the pharmaceutical and medical devices sectors.
On the positive side, it highlights how a number of manufacturing units are doing an excellent job and their facilities and compliance standards are at par with the best in the world. It has been pointed out that the repeated inspections by regulators of importing countries have led to a massive improvement in their conformance with quality parameters that have continued to be scaled up progressively. The Productivity Linked Incentive schemes relating to pharma and medtech sectors launched recently have been analyzed in detail and 121 recommendations have been made to spruce up the sectors.
The book unravels many hidden secrets and presents a compelling context for the government and the Indian pharmaceutical and medtech industry to wake up and take prompt, corrective and preventive action. The book goes a long way in filling up the wide gaps in the existing literature on the subject and the findings of the regulators of countries importing medicines from India.