IMA policy is to prescribe quality drugs at affordable cost
Bioequivalence studies are an important aspect of making medicine affordable
New Delhi, 24 December 2017: In what can be called a long overdue move, the Ministry of Health and Family Welfare amended the law to make bioequivalence studies compulsory for certain classes of generic drugs manufactured in India this year. The Drugs & Cosmetics Rules, 2017 was formally amended through a notification on April 3 to incorporate the change. The new law required bioequivalence studies to be performed on drugs with low solubility.
Bioequivalence studies are studies conducted to establish that two medicines, normally the original patented drug and a generic version, have the same biological equivalence – that is, that they work the same way, to the same extent and for the same purpose.
Speaking about this, Padma Shri Awardee Dr K K Aggarwal, National President Indian Medical Association (IMA) and President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement, said, “The most important characteristics of any drug is its Bioequivalence to the innovator product to prove its safety, clinical efficacy equivalence and cGMP compliance on continuous basis for sustainable supply. The BE of any drug depends on its formulation process, choice of excipients, dissolution profile, stability under different conditions to prove its claimed shelf life, in process manufacturing and quality controls, packaging, storage conditions, transportation, validation studies, annual stability data review, analytical testing validated procedures, continuous engineering maintenance of every equipment in the plant, continuous training and development of people, reviewing regularly manufacturing/plant/site data, taking action on deviations e.g. Out of Specifications, Out of Limit, batch specific deviations, change control, presence of impurities and mode of release of the drug etc. to name a few.”
IMA is for affordable, accessible and quality healthcare. IMA policy is to prescribe quality drugs at affordable cost. IMA promotes usage of drugs from NLEM (National List of Essential Medicines).
Adding further, Dr Aggarwal, said, “To promote Pradhan Mantri Bharatiya Jan Aushadhi Pariyojana, IMA has opened a Pradhan Mantri Bharatiya Jan Aushadhi Kendra (PMBJK) in the premises of its headquarters and recommends such Kendras should be opened in all the IMA buildings in India. Doctors are committed to the welfare and safety of patients. Economy of drugs is only one dimension of the issue. IMA shall remain the voice of voiceless and continue its service in nation building diligently.”
Seven steps for Government of India.
· Raise the Government expenditure on Health to 2.5 % of GDP from the current abysmal 1.1%.
· Strong overview and monitoring by DCGI and State Drug Controllers on compliance to cGMP practices in drug industry.
· Strengthen the quality assurance infrastructure to the required level so that the quality of every batch of drugs is assured.
· Deploy adequate regulatory manpower to enforce the laws regarding drugs.
· Stop over-the-counter (OTC) sale of prescription drugs without a prescription and do not allow a company to market same drug in different prices under different brands.
· Prevent quacks and alternative system from using modern medicine drugs.Initiate awareness movement amongst doctors and patients to buy quality affordable drugs.