With the steady increase in the volume of imports into India, the Government of India has introduced stricter standards to ensure compliance with quality standards in India. These laws serve two essential purposes: i) establish and enforce standards of various parameters in order to streamline or regulate trade and commerce, and ii) protect the consumer’s rights.
One key aspect of these laws is providing the consumer with all necessary information, so that the consumer makes an informed decision. This is done by clearly mandating the declarations to be made on the labels of the products prior to their sale in India.
Certain goods that are consumed directly by humans require strict compliance not only with the quality parameters but also with the labelling requirements. These goods may be food articles, pharmaceutical products, cosmetic products, etc. For each of these products, the Government has introduced numerous specific rules and regulations. The Drugs Rules, 1945 have been introduced for governing various types of medicine and cosmetics, and their labels. Similarly, for food articles, the Government has implemented the Food Safety and Standards (Labelling and Display) Regulations, 2020. The Medical Devices Rules, 2017 have been introduced for regulating labelling of medical devices.
However, these product specific laws are not exhaustive. For example, Bureau of Indian Standards (‘BIS’) has also issued various standards for medical instruments and devices. The Legal Metrology (Packaged Commodities) Rules, 2011 (‘LM Rules’) govern labelling of pre-packaged commodities, irrespective of whether they are food articles, cosmetics, medical devices, etc.
Thus, while certain laws target goods by category: food, drugs, etc., there are others which target goods based on other aspects like form of packaging (LM Rules) or applicability of quality standards (BIS). By virtue of the ambit of these laws being varied, a single product might require complying with labelling requirements set out in more than one law. In this background, the labelling requirements prescribed under different laws for the same product need to be examined.
LM Rules - References to other laws and exceptions carved qua the same
The LM Rules are general rules to be followed for the manufacture, import, sale or distribution of ‘pre-packaged commodities’ i.e. a commodity which, without the purchaser being present, is placed in a package of whatever nature, whether sealed or not, so that the product contained therein has a pre-determined quantity. An example of a pre-packaged commodity could be a packet of chips or a shampoo bottle, the contents of which are of a pre-determined quantity and by the very nature are required to be packed before they are sold. Thus, by virtue of it being applicable to all pre-packaged commodities, these Rules have a very wide ambit, affecting goods across different sectors.
The LM Rules stipulate the declarations and the manner in which declarations are to be made on the packages. As per the Rules, every package / label affixed thereon is required to declare name and address of the manufacturer and the packer or importer, the country of origin or of manufacture or of assembly, common or generic names of the commodities, net quantity, month and year of manufacture, best before date, etc.
Compliance with these LM Rules is mandatory if the product is a pre-packaged commodity. However, does compliance with this general law absolve the business from complying with the labelling requirements under other specialized laws? For instance, does applicability of LM Rules dispense with the requirement of the packet of chips to comply with labelling requirements under the Food Safety and Standards (Labelling and Display) Regulations, 2020? Or the bottle of shampoo from declaring on the label the directions set out in Cosmetics Rules, 2020? The answer is: No.
Each of these laws seeks to tackle different aspects of the product and endeavors to provide the consumer with the information, which is considered relevant, key under that particular law. What is relevant/key under one law need not be so under another law. However, it is most important that mandates under all applicable laws are complied.
However, the LM Rules carve out a few exceptions for the applicability of certain specific rules instead of the LM Rules. The declarations to be made under the LM Rules and the exceptions to the Rules are tabulated below:
| Declarations to be made under the LM Rules | Whether LM Rules provide for any exception for specific law to apply over Legal Metrology law |
| Rule 6(1)(a) mandates declaration of the name and address of the manufacturer and the importer / packer. | As per Explanation III, this clause shall not apply to food articles, but the provisions of, and requirements under the Food Safety and Standards Act, 2006 and the rules made thereunder shall apply |
| Rule 6(1)(d) mandates the declaration of the month and year of manufacture of a commodity |
The rule provides for various exceptions as follows: |
| As per Rule 6(1)(da) if a commodity may become unfit for human consumption after a period of time, it is required to mention the ‘best before or use by the date, month and year’ on the label | As per the proviso to this clause, nothing in this clause shall apply if a provision in this regard is made in any other law. |
Thus, the overriding effect of specific laws over the LM Rules is only for certain declarations, i.e. only where it is specified. The general mandate is that the LM Rules must be complied with, in addition to any specific laws.
The specific laws vary with LM Rules in numerous ways. To illustrate this, a few differences are highlighted below:
1. Manner of making declaration: LM Rules mandate declaration on the external packaging of the product. Under the Drugs Rules, 1945, labels must be put up on the innermost containers too.
2. Nature of declaration: Over and above the declarations needed under LM Rules, Medical Devices Rules, 2017, mandate additional declarations such as warnings or precautions, distinctive batch number, etc.
3. Difference in interpretation: The definition of manufacturer under the LM Rules - even a brand owner, importer can claim themselves to be manufacturer (as the purpose of the act is to fasten liability for any violation in declarations). However, under the labelling mandate under BIS, only the name of actual manufacturer in whose factory the product was produced can be declared to be the manufacturer. Thus, compliance with one law might amount to violation under another law.
Therefore, compliance with one law does not absolve an importer from applicability of another law operating in a similar area. Importers must be aware of all laws applicable to their product and must ensure complete compliance with the same and must be careful to ensure that compliance under one law does not amount to violation under another law.
[The authors are Associate and Partner, respectively, in Customs practice at Lakshmikumaran & Sridharan Attorneys, Mumbai]
