Drugs and Public Health
The Drug Rules are exhaustive and they spell out the medicines which can be given only on prescription and those that do not require prescription. The rules also specify when a particular drug will be treated as of standard quality. They provide for detailed instructions concerning manufacture, storage and sale. There are also detailed guidelines concerning the conduct of clinical trials. Quality control in drugs is sought to be ensured through licensing and supervision procedures.Section 17. Misbranded Drug
- for the purposes of this Chapter, a drug shall be deemed misbranded-
- If it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
- If it is not labeled in the prescribed manner; or
- If its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
- A drug shall be deemed to be adulterated-
- If it consists in whole or in part, of any filthy, putrid or decomposed substances; or
- If it has been prepared, packed or stored not under sanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health;or
- If its container is composed, in whole or in part, of any poisonous or deleterious substances which may render the contents injurious to health; or
- If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or
- If it contains any harmful or toxic substance which may render it injurious to health; or
- If any substance has been mixed there with so as to reduce its quality or strength.
- A drug shall be deemed to be spurious-
- If it is manufactured under a name which belongs to another drug; or
- If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
- If the label or container bears the name of an individual or company purporting to be the manufacture of the drug, which individual or company is fictitious or does not exist; or
- If it has been substituted wholly or in part by another drug or substance; or
- If it purports to be the product of manufacture of whom it is truly a product
- From such date as may be fixed by the State Government by notification in the official Gazette in this behalf, no person shall by himself or by any other person on this behalf-
- Manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute) Any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
- Any cosmetic which is not of a standard quality or is misbranded or spurious;
- Any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities, thereof;
- Any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to prevent, cure or mitigate any such disease or ailment, or to have any such other effect as may be prescribed;
- Any cosmetic containing any ingredient, which may render it unsafe or harmful for use under the directions, indicated or recommended vi) Any drug or cosmetic in contravention of any provision of this Chapter or any rule made there under;
- Sell or stock or exhibit or offer for sale, distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made there under;
- Manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the condition with the conditions of, a licence issued for such purpose under this Chapter Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis.
- Provided further that the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale or for distribution, sale stocking or exhibiting or offering for sale or distribution of any drug or class of drugs not being of standard quality.
- Subject to the provisions of this Act, no person shall take ‘any part in the publication of any advertisement’ referring to any drug in terms which suggest or are calculated to lead to the use of that drug for-
- Procurement of miscarriage in women or prevention of conception in women; or
- Maintenance or improvement of the capacity of human beings for sexual pleasure; or
- Correction of menstrual disorder in women; or
- Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called) which may be specified in the rules made under this Act: Provided that no such rule shall be made except-
- In respect of any disease, disorder or condition which requires timely treatment in consultation with a registered medical practitioner or for which there are normally no accepted remedies, and
- After consultation with the Drugs Technical Advisory Board constituted under the Drugs and Cosmetics Act, 1940 and, if the Central Government considers necessary, with such other persons having special knowledge or practical experience in respect of Ayurvedic or Healthcare Case Unani systems of medicines as that Government deems fit
- Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which-
- directly or indirectly gives a false impression regarding the true character of the drug; or
- makes a false claim for the drug; or
- is otherwise false or misleading in any material particular.
The Supreme Court has concluded:
- Licences under Rules 61 & 62 proviso will extend to grant of licences for wayside depots or ‘emergency stores’ or ‘vehicles’, but every storage for sale must have a licence.
- Licences permitting sale by a vehicle cannot automatically cover cases of ‘emergency storage’ or storage in transit. The words of Section 18(c) and Rule 62 are mandatory being plain and admitting no exceptions.
- Applying the mischief rule of interpretation, storage even though for a short spell or on an ad hoc basis and without intent to sell at that place but as a part of the sale business comes within the scope of ‘storage for sale’ in Section 18(c) & Rule 62.
The amendments to the Patents Act coupled with India’s obligation under TRIPS, and the increasing efforts by pharmaceutical companies to profit from the changes in the law. The new Patents Act is characterized by two main trends.
On the one hand, it generally follows quite closely the requirements of the TRIPS Agreement. The amendments made generally favour the drug/process developer over the society. The duration of patents in the health sector has been, for instance, dramatically increased from seven to 20 years. On the other hand, the new Patents Act uses some of the exceptions and qualifications included in TRIPS to foster public health goals. It uses, for instance, health-related exceptions in Sec.3 of the Act which determines which inventions are not patentable.One of the most controversial sections is regarding licensing.
While TRIPS generally imposes a stricter compulsory licensing regime than that provided under the Patents Act, 1970, the amendments make use of some of the possibilities opened by the Doha Declaration. It specifically mentions that patents granted should not ‘impede protection of public health’ and should not prohibit the Central Government from taking measures to protect public health. Further, it recalls that patents should be granted to make the benefits of the patented invention available at reasonably affordable prices to the public.