There are 11 major Acts and four other notifications of the government that empower the government to take action against illegal hoarding, black-marketing and over-pricing of essential drugs, medicines and essential medical services.
@prashanthamine
Mumbai: Did you know that your retail dispensing Chemist is bound by law to display the price list, the supplementary price list, if any, as furnished by the manufacturer on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same?
These and many more important provisions are notified in The Drugs (Prices Control) Order of 2013 (DPCO).
But hardly any of these provisions in law are ever followed by anyone or are made known to the end consumer.
It is even a bigger mystery as to why the government’s are failing to exercise the powers vested in them at a time when people are finding it extremely difficult to procure essential drugs like Remdesivir injections, Liquid Medical Oxygen (LMO) and hospital beds for their ailing loved ones.
As per The Drugs (Prices Control) Order, 2013 (DPCO), “every retailer and dealer shall display the price list and the supplementary price list if any, as furnished by the manufacturer, on a conspicuous part of the where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same”.
The DPCO further states “No person shall sell any formulation to any consumer at a price exceeding the price specified in the current price list, or price indicated on the label of the container or pack thereof, whichever is less”.
Furthermore, the DPCO adds, “No dealer shall sell loose quantity of any formulation at a price which exceeds the pro-rata price of the formulation. No dealer, manufacturer, distributor shall withhold sale, or refuse to sell to a dealer, customer intending to purchase such a drug”.
Similar provisions are contained in The Drugs (Display of Prices) Order, 1962. The Central Drugs Standard Control Organisation (CDSCO) is mandated to ensure that the laws are followed in letter and spirit.
Did you know that The Drugs (Control of Prices) Order, 1962 and The Drugs (Control of Prices) Order, 1963, promulgated under The Defence of India Act, 1962, the prices of Drugs has been freezed since April 1, 1963.This was done then in view of the sky-rocketing prices of essential medicines following the Indo-China war of 1962. The law was subsequently amended in 1971.
As per the provisions of The Defence of India Act, 1962 and 1971, the government can while exercising its emergency powers for maintenance of public order, can take steps for maintaining supplies and services essential to the life of the community. It may be recalled that India had lodged a strong protest after US, President Joe Biden had invoked similar provisions in the Defence of US Act stopped exports of raw materials needed for vaccine production in countries like India.
It may be further recalled that recently the Uttar Pradesh government has invoked more stringent provisions of the National Security Act, 1980 (NSA) against some medical representatives and hoarders of Remdesivir injection.
The NSA also provides for provisions to maintenance of essential supplies and services essential to the community. It provides for more stringent provision for detention of any persons for a period ranging between three months to six months without obtaining the opinion of the Advisory Board.
The DPCO, 2013 lays down the norms for calculating the Maximum Retail Price (MRP) of a drug, fixation of ceiling price of scheduled formulations and monitoring the availability of scheduled formulations.
The DPCO, 2013 has brough within its ambit even future vaccines that will be developed. The order not only mandates monitoring availability of the drugs, but also of its active pharmaceutical ingredients as well.
Like the manufacturer of a scheduled drug has to inform six months in advance of any discontinuation of any scheduled drug, the government can also direct the manufacturer to continue the production of the scheduled formulation for a period of one year or its import.
The DPCO further mandates that the manufacturer has to maintain all the records relating to production, sales of individual or bulk drugs and that the government has the powers to call for inspection of all such records at the premises of the manufacturer.
The National Pharmaceuticals Pricing Authority (NPPA) has been set up the Department of Pharmaceuticals under the Union Ministry of Chemicals and Fertilizers. The NPPA has in its notification of February 27, 2019 cited two judgments of the Karnataka High Court and the Punjab and Haryana High Court over the pricing of essential medicines.
The Karnataka HC judgment of November 12, 2002 in the K S Gopinath and others – vs – Union of India which was later upheld by the Supreme Court of India (SC) on March 31, 2011, had “directed the government to ensure that lifesaving drugs do not fall out of price control”.
The Punjab and Haryana HC in its judgment of March 19, 2013 in the Ranbaxy Laboratories Ltd – vs – State of Haryana and others had noted “that although the petitioner is allegedly selling the drug in question to the consumers at about 900% of the reasonable price of the drug, but there appears to be no legal provision in force to save the consumers by the petitioner or any other manufacturers by – pricing the drug to such an extent”.
The same NPPA in its notification admits to, “One major factor that contributes to high drug prices in India, is the unreasonably high trade margins. Trade margin is the difference between the price at which the manufacturers sell the drug to the stockist/distributors (price to stockist) and the final price to patients (MRP)”.
Then there is the National List of Essential Medicines (NLEM) which contains the list medicines declared by the government as “essential medicines”. It means that the prices of these essential drugs are regulated and their availability is monitored. At present the NLEM has 376 medicines in the list, out of which 59 drugs are already under the category of Anti-neoplastic/Immunosuppressive, Hormones, Anti-Hormones and medicines used for Palliative care.
Besides these, The Drugs & Cosmetics Act, 1940, The Drugs & Cosmetics Rules, 1945, The Prevention of Black Marketing And Maintenance of Supplies of Essential Commodities Act,1980, The Essential Commodities Act, 1955, Maharashtra Essential Services Maintenance Act, 2011, The Epidemic Diseases Act, 1897, The Disaster Management Act, 2005, The Maharashtra Nursing Home (Amendment) Act 2006, and the Bombay Public Trusts Act, 1950 the government can act against illegal hoarding, black-marketing, ensure supplies of all essential medicines and services in times of medical or natural emergencies.
As per The Prevention of Black Marketing And Maintenance of Supplies of Essential Commodities Act,1980, the government can take action against those acting in any manner prejudicial to the maintenance of supplies of commodities essential to the community.
Furthermore, as per The Essential Commodities Act, 1955, (ECA) the government can intervene and take action under the law or any other law for the time being in force relating to the control of the production, supply or distribution of, or trade and commerce in, any commodity essential to the community. The Act also provides for scheduled drugs to be brought under the purview of essential commodities and provides for a jail term of one month, or a fine of Rs 2,000, or both under the provisions of the Criminal Procedure Code (Cr PC), 1973.
The Maharashtra Essential Services Maintenance Act, 2011 (MSEMA) empowers the government to take action in respect of “Any service connected with maintenance of public health and sanitation including hospitals and dispensaries”.
If that is not enough the Maharashtra government through two separate notifications of April 30, 2020 and May 21, 2020, has put restrictions on charges levied by private hospitals on medical, surgical procedures, reserve 10% of beds in hospitals run by charitable trusts for free of cost to indigent patients and further reserve 10% beds at concessional rates for weaker sections of the society.
