The cost of medicines constitutes a large percentage of the total medical costs of an individual or a household in India. Despite vast improvement in government's healthcare spending over the last 25 years, there has been no respite on steadily rising medical costs in the country.
As over 95 per cent of the country's population is not covered by medical insurance, such medical costs continue to be unaffordable to the common man. At the same time, the price control on drugs is almost non existent and most of the 500 new drugs marketed in the country are outside the purview DPCO.
Currently, fast moving branded generics marketed in the country are either manufactured by MNCs or large Indian companies. It is well known that prices of their drugs are usually expensive. Now with more Indian companies are being acquired by MNCs, the trend of high prices for essential drugs is going to continue in future. These branded generics are expensive because they are strongly promoted through doctors and chemists. And the pharmaceutical companies usually add the promotional costs to the cost of the drugs.
The branded drugs incur 30 per cent to 80 per cent of the MRP towards costs of promoting medicine through MRs, doctors, retailers etc. Due to market imperfections there is hardly any relationship between cost of raw materials and the final price. Incentives to doctors or trade are several times that of actual cost of bare medicine in the final price.
At the same time unbranded generics/ unpromoted brands from reputed companies such as Ranbaxy, Cipla, Wockhardt, etc, cost a fraction of those promoted brands.
Jeveendhara Sanjeevani drug store scheme is designed to offer all medicines that are required by patients, considering today’s realities with double assurance of quality based on best practices like a formulary development, formulary committee, scientific guidelines to assure quality, proven capabilities of manufacturers.
This provides an opportunity to procure unbranded generic medicine/unpromoted branded medicines at a fraction of MRPs of their branded counterparts. Under this scheme generics are given at 50 to 90 per cent discount on MRP. At present products of only 25 top companies are being stored.
This opportunity has potential to revolutionize affordability of quality essential medicine especially in case of chronic/acute therapies.
Under Janaushadi scheme medicines from four public sector undertakings and canalised procurement are made available through the Janaushadhi stores.
What is double assurance of quality?
It is an established fact that chemical equivalence does not mean clinical equivalence. In India, bioeqivalence is required only in the first four years of a new product where license is given by DCGI, Govt. of India. In all other cases bioequivalence is not required.
However, all major FDAs such as US FDA, UK MHRA, MCC South Africa, TG Australia, Health Canada, etc., require bioequivalence for most of product approvals. Indian State Drug Approval authorities do not require bioequivalence.
Further, change of site of production, change of source of API, change of process, etc. require in-depth proof of equivalence.
When generics are sold at lower price, there may be lot of misinformation campaign, negative publicity, etc. Hence we should be more cautious to safeguard quality. Hence a ‘Formulatory Committee’ comprising professionals, pharmacists and experts from industry was established for doubly ensuring quality.
Assuring quality in medicine procurement
Based on criticality of bioequivalence, US FDA has identified various drugs into different classes such as AA, AB, etc. Further, BCP classification based on solubility, permeability, etc., classifies drugs into four classes such as BCP1, BCP2, BCP3 and BCP 4.
Drugs, falling under AA/BCP1, etc., are known to behave consistently and does not require proof of bioequivalence and hence are permitted to be procured from any manufacturer in most countries.
For classes of medicine where bioequivalence is critically important, such as AB drugs or BCP 2 and above it is proposed to initially procure such medicine from reputed manufacturers having approvals from FDAs such as US FDA, MHRA, MCC, etc.
Such procurement strategy is expected to result in availability of quality medicine as those manufacturers can not afford to tarnish their image in view of their business with those countries.
Jan Aushadi scheme assures quality based on the fact that a drug is approved by state or central govt. Jeevandhara Sanjeevani concept goes beyond that and looks for additional quality assurance guarantees.
The concept of Jeevandhara Sanjeevani is successfully tested in Visakhapatnam District.
The roadmap
■ Appoint a state level programme coordinator for Jeevandhara Sanjeevani concept
■ Expand Formulary by approving products for all targeted diseases. Further document all the guidelines and approval systems in developing such formulary.
■ Expand current Standard Operating Procedures (SOPs) to manage the procurement at state level. Develop a common warehouse and reach all stores through approved distribution system. Monitor drug prices dynamically for all medicines by reaching directly all leading companies and wholesale distributors. Present best options on a monthly basis to the formulary committee and obtain procurement plans.
■ Establish Jeevandhara Sanjeevani retail stores in all district headquarters, major towns and hospitals across the state by providing one standard room , accessible to public.
It is suggested that at least 1,000 retail pharmacies can be opened in the phase – I. All metro cities like Hyderabad can be targeted easily where in the available infrastructure at various hospitals can be used immediately and the information can be disseminated.
Every drug stores should have a retail license from Drug control department. It is envisaged to percolate to every PHC level increasing the number of retail pharmacies in phase – II.
This article is based on a presentation by Formulary Committee including
J. Syamala Rao, Dist Collector, Dr PV Appaji, Executive Director Pharmexcil, Lanka Srinivas,
Advisor, Pharmexcil and Uday Bhaskar, ADC, Vizag and Secretary General, AIDCOC.