Saturday, September 11, 2010

Consumer rights of patients while buying medicines

Poor knowledge among common masses in relation to the rights of drug consumers and lack of awareness about other legal provisions on drug usage is fraught with several unwanted manifestations like insufficient and inappropriate retaliatory response on part of the consumers in the event of any drug proving out to be misbranded, adulterated, spurious or not of standard quality. Drugs are consumed by the people of J&K in immensely large quantities. Enhanced knowledge about legal safeguards envisaged by the existing drug laws in the state is the most reliable way to safe and effective use of standard quality drugs. This article is an attempt towards armoring the consumers of drugs with the basic knowledge of their rights, protection offered to them by the statutory provisions and retaliatory measures to be undertaken by them in the event of any violation of norms by drug dealers or manufacturers.

Many a times when we purchase or consume drugs and confront different situations related to their usage, we find ourselves at our wit’s end and desperately need answers to several questions haunting our minds like what should be done if a dealer does not issue a cash memo upon sale of drugs? Can a chemist refuse to sell medicines upon being asked to issue a cash memo against the drugs purchased or under other circumstances? Can a consumer himself initiate legal proceedings against a substandard or spurious drugs dealer or manufacturer in the event of a strong and sound suspicion on the quality or effectiveness of a drug? Can a consumer get it tested at Govt. laboratories on his own without relying on the enforcement staff or can any relevant non-governmental organization undertake testing or analysis of drugs in an independently established Drug Testing Laboratory whose test reports are accepted and honored by the court of law? Can physician’s samples be stocked by drug dealers within their sale premises and many such questions.

Next time when you feel the drug which you have consumed is not yielding desired results or its appearance, labeling or purity seems reasonably doubtful, you can send the drug sample for testing on your own either to the state owned drug testing laboratory or central drug testing laboratory at Ghaziabad. Section 26 of the Drugs and Cosmetics Act, 1940 enables a purchaser of drug or cosmetic to submit for test or analysis to a Govt. Analyst any drug or cosmetic and to receive a report of such test or analysis duly signed by the Govt. Analyst. On the basis on the test report obtained therefrom, under section 32 of the said Act, a purchaser of a drug, the person aggrieved, any recognized consumer association or any other NGO can launch a prosecution on its own against the dealer and/or manufacturer of the drug, in the court of a metropolitan magistrate or of a judicial magistrate of the first class. Depending upon the nature of offence committed, court can then award a suitable punishment to the offenders under section 27 of the said Act. A fact little known to common masses is that even heads of various govt. departments are liable to punishment in case any offence has been committed by their departments. Section 34A of the D & C Act, 1940 states that where an offence has been committed by any department of government, such authority as is in charge of manufacture, sale or distribution of drugs or the head of that department shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly.

The number of drug samples required to be lifted for the purpose of testing annually in order to know the actual standards of quality of drugs available in our markets is too large and the facilities and infrastructure available with our state to coop up with the load is too scarce. Under these circumstances we cannot entirely rely on govt. testing laboratories and need to take some initiatives in this regard. Registered consumer associations or NGOs can with the help of trained individuals establish private drug testing laboratories and get them duly approved as provided under Part XVA, Rule 150 B-K of the Drugs and Cosmetics Rules, 1945. Such laboratories can also be established in various medical or educational institutions dealing with general healthcare and can carry out tests on drugs and raw materials used in their manufacture on behalf of manufacturers or dealers of drugs. This way they can earn some revenue too for their respective institutions. However the pre-requisite for such laboratories is that they have to be got approved by the CDSCO under the Act.

Rule 65 (3,4) of the D & C Rules, 1945 provides that the supply by retail of any drug shall be made against a cash or credit memo which shall contain all necessary particulars like name, address and sale licence number of the dealer; serial number of the cash/credit memo; the name, quantity and batch number of the drug supplied and in case of a biological product its date of expiry too. Finally each cash or credit memo issued should bear the signature of the person under whose supervision the sale is effected. No dealer can refuse to issue a cash/credit memo against a sale of drugs and any such act is an offence. Many a times it so happens that when a customer demands cash memo from the dealer against a small quantity of drugs sold by him, he plainly refuses to sell the drug itself. As per Para 18 (b) of the Drug Prices Control Order, 1995, no dealer can withhold from sale or refuse to sell any drug available with him to a customer intending to purchase such drug. Such a denial even if caused during the closing hours of the drug store is a serious offence.

As per Para 16 (4) of the DPCO, 1995, every retailer and dealer has to display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, 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. However hardly do we find any drug sale establishment displaying the price list of drugs within the premises. Though prices are clearly indicated on the containers of drugs, prior to the implementation of VAT regime, taxes were being charged by the drug dealers as per their own whims and fancies. New regime has brought some respite to the customers in this regard. Penalties in cases of any overcharging on drugs have to be awarded in accordance with the provisions of Essential Commodities Act of 1955, as stated under Para 24, however no field staff entrusted with the job of maintaining a check over drug prices has been notified under Essential Commodities Act as is essential for any legal proceedings in such cases.

It has been seen that most of the drug dealers often stock expired drugs in combination with the remaining live stock on the plea that drugs do not get expired soon in our valley due to low temperature or humidity. Some of them even indulge in the sale of such drugs on this pretext without any hesitation. However, Rule 65 (17) of the D & C Act, 1940 provides that no drug should be stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper. However any such drug in respect of which the licensee has taken steps, with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiry pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same be stored separately from the remaining stock, in packages or cartons, the tops of which shall display prominently the words, “Not for Sale”. Therefore no drug dealer has any right to stock or sell any drug on any pretext beyond its date of expiry.

Similarly with regards stocking of Physician’s Samples within sale premises, Rule 65 (18) reads that no drug intended for distribution to the medical professionals as free samples and no drug meant for consumption by the govt. hospitals or medical store depots, which bear distinguishing marks like “Physicians’ samples, not for sale” or “Hospital supply, not for sale” shall be sold or stocked by the drug licensees on their premises. Another practice that is very common with our drug dealers is the substitution of brands prescribed by the physician on their own. Rule 11 A of the said Rules prohibits every person dispensing a prescription containing substances specified in Schedule H or X, commonly known as prescription products, from supplying any other preparation, whether containing the same substance or not in lieu thereof. Any person indulging in such practices which are in contravention to the provisions of chapter IV of the D & C Act, 1940 is liable to a punishment with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine, as provided under section 27 (d) of the said Act.


These are some of the prominent issues commonly confronted by drug consumers regarding which they need to remain fully aware in order to safeguard their interests. Unscrupulous dealers indulging in the trade of substandard drugs take undue advantage of the ignorance prevailing among masses regarding the drug laws in force and their rights afforded by the law of the land. As such illegal trade keeps flourishing unabated and there is hardly any practical resistance offered by the end-users of drugs. Need of the hour is to create mass awareness on all related issues and sensitize the consumers about their rights and duties towards themselves as well as towards the society.

No comments:

Post a Comment