Recently, the Legal Metrology Division of the Department of Consumer Affairs issued a notification about the applicability of the Legal Metrology (Packaged Commodities) Rules of 2011 on Medical Devices. The Legal Metrology Act provides rules and regulations for the weights, measures and products sold in weight and measurement. The Legal Metrology (Packaged Commodities) Rules were issued to further govern the packaged commodities. While the Act talks about weights and measures primarily, the said rules specifically target packaged commodities. The most common examples of these packaged commodities are the snacks, biscuits and groceries you buy daily. Let’s see how the new notification will affect manufacturers and distributors of medical devices.

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Applicable and Relevant Laws

The following laws are involved and discussed in the present notification issued by the Department of Consumer Affairs. The objectives of these laws are given below-

• Legal Metrology Act: This law establishes fair standards for weights, measures, and goods sold or distributed by weight, measure, or number. It regulates trade and aims to ensure fairness in commerce.
• Legal Metrology (Packaged Commodities) Rules: These rules describe how the declarations and other information must be printed on the packaging of commodities and prescribe rules for the maximum allowed error in new weight measurement.
• Essential Commodities Act: This act regulates essential commodities. It aims to control how these essential commodities are made, supplied, and sold to the public. It's to protect and benefit everyone in trade and commerce.
• Drugs Price Control Order: This order was passed under the Essential Commodities Act to regulate the pricing of drugs or any other products that are declared as drugs by the competent authority.

Exemption for Drugs under Legal Metrology Rules

The Legal Metrology (Packaged Commodities) Rules have exemptions for some packages defined in Rule 26. It has listed four types of packages which do not fall under the purview of Legal Metrology Rules and nothing mentioned in these rules applies to the exempted products. These four products are as follows-

• Commodities of less than 10 grams or 10 millilitres.
• Fast Food or similar Items packed by restaurants or hotels.
• Scheduled and Non-Scheduled Formulations that are covered under the Drugs (Price Control) Order of 1995.
• Agricultural products in packages of 50 kg or more.

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Notification About Medical Devices

The clarification is regarding the third exemption as provided above. The Department of Consumer Affairs has clarified by issuing a notification that the medical devices will not be exempted under clause c of Rule 26 of the Legal Metrology (Packaged Commodities) Act if they are declared as drugs. When medical devices were new to the industry they were declared as drugs and they needed to follow the pricing rules as described under the Drugs (Price Control) Order. But now as per this notification, the rules prescribed in Legal Metrology Act shall apply to medical devices as well.

The Legal Metrology Rules also mention in Rule 6 that the maximum retail price of a commodity shall be affixed on the package with an indication that it is the maximum retail price inclusive of all taxes. But the state laws shall be applicable for alcoholic beverages and spirituous liquor. If in any state no such law is applicable then the provisions of Legal Metrology Rules shall apply. In addition to these provisions, the present notification says if an appropriate authority fixes and notifies the maximum retail price of an essential commodity then the same shall apply.

Old and New Pricing for Medical Devices

Since February 2020, medical devices were exempted from the provisions of Legal Metrology Rules by virtue of Rule 26 (c). Instead, they were regulated under the Drugs Price Control Order of 1995 because all medical devices were declared as drugs. With the changes made above and clarifications issued by the Department of Consumer Affairs, Medical Devices are no more exempted from Legal Metrology (Packaged Commodities) Rules. Till now the pricing was determined under the Drugs Price Control Order but now it will be decided based on the Essential Commodities Act. The packaging of these medical devices will be governed by the Legal Metrology (Packaged Commodities) Rules.

How Will it Affect the Price of Medical Devices?

Competent authorities will now issue guidelines using the power conferred to them under the Essential Commodities Act regarding the pricing of medical devices. This notified pricing shall apply from now on instead of the former Drugs Price Control Order.

Read Our Blog: How to Obtain a Legal Metrology Certificate in Chennai

Conclusion

In conclusion, the recent notification removes the exemption of medical devices from the Legal Metrology (Packaged Commodities) Rules. Instead of being regulated by the Drugs (Price Control) Order, medical device pricing will now be governed by the Essential Commodities Act and the Legal Metrology Packaged Commodities Rules. Competent authorities will issue guidelines for pricing, and compliance with the Legal Metrology Act will be crucial for businesses in the industry. This change aims to ensure fair trade practices, consumer protection and customised policy implementation for a dedicated medical product category. Stakeholders must adapt to the new regulations for a successful implementation.