The Indian Pharmacopoeia (IP) is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of this pharmacopoeia are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines.
The actual process of publishing the first Pharmacopoeia started in the year 1944 under the chairmanship of Col. R. N. Chopra under the British Regime. The I. P. list was first published in the year 1946 and was put forth for approval. First edition of I.P published in the year 1955 followed by the 8th edition in 2018. Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia because I.P is conceptualised by British Government.
The IP 2014 which is 7th edition, incorporates 2567 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, herbal products, biotechnology products and radiopharmaceuticals etc. IP-2018 has been brought out in 4 Volumes incorporating 220 new monographs (Chemical Monographs (170), Herbal Monographs (15), Blood and Blood related products (10), Vaccines and Immunosera for Human use monographs (02), Radiopharmaceutical monographs (03), Biotechnology Derived Therapeutic Products (06), Veterinary monographs (14)), 366 revised monographs and 7 omissions.
Significance of I.P over USP & B.P
Keeping in view the essential requirement for harmonization of analytical methods with those accepted internationally, steps have been taken for monitoring drug standards.
India is manufacturing medicine for approximately 200 countries and saving valuable life of human being and other living organisms. Manufacturers have to take many administrative documents in case of U.S.P & B.P formulations to manufacturer sample for dossier documentation and registration. It requires more than 6-8 months. Procurement of raw materials, reference standard and impurities in U.S.P & B.P are again time taking and challenging.
It is hoped that acceptance of I.P across the world would play a significant role in improving timely demand and supply of medicines which in turn promote public health and accelerate the growth and development of Pharma Sector.
Conceptualize and documented by Mohammad Shahbaz Alam
For every challenge we face - unemployment, poverty, crime, income growth, income inequality, productivity, competitiveness - a great education is a major component of the solution. From Jawaharlal Nehru to Narendra Modi or any prime minister of India cannot fulfil commitment of employment because they do not know how. They do not know demand supply chain. Indian pharmaceutical industry is providing 10 million jobs for skilled and unskilled workers.
Trump over and again creates buzz of false nationalist to grab the media coverage. It is trend now globally, politicians talk in all front without validated data. We strongly disagree with the observations made by USTR that India and China are involved in manufacturing substandard generic medicine. USTR is The Office of the United States Trade Representative is the United States government agency responsible for developing and recommending United States trade policy to the President of the United States.
It is an old adage “Rome was not built in a day “Similarly global super power tag not attached to Indian Pharma Industries in a day. Regulators worked day and night in policy making, implementation and coordination with industry and global regulatory agencies for better administration. Two Singham, Dr.Surender Singh & Dr.G.N.Singh made CDSCO proactive and stronger in terms of transparency and administration.
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.
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