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Expressing displeasure over the extension of deadline for implementation of Legal Metrology (Packaged Commodities) Amendment Rules till July, the Association of Indian Medical Device Industry (AiMeD) has said that the rules should be implemented at the earliest to ensure product quality thereby protecting the interest of consumers.
The amended rules seeking to regulate pre-packaged commodities, has made it compulsory for manufacturers/ packers/importers to make declarations about country of origin, date of manufacture, quantity, expiry date among other details of product. It was supposed to be implemented from January 1st this year. It was extended upto the end of January this year following the representations from manufacturers/ packers/importers. The department of consumer affairs further relaxed the deadline till February, then April this year. The April deadline has now been extended till end of July.
As per the revised rules, manufacturers are also required to increase the font size of product details, so consumers can read them easily. Barcoding product details, although voluntary, has also been mentioned in the new rules. The government has made it clear that in the initial months of implementation of the said rules, no one will be prosecuted for failing to comply with labeling requirements.
Welcoming the Legal Metrology Rules, Rajiv Nath, Forum Coordinator of AiMeD said “The aim of rules is to safeguard consumers. Indian medical device makers are ready to comply with the rules. Its implementation should not be delayed. We request level playing field in enforcing these Rules between foreign manufacturers and Indian manufacturers. The rules should be further amended to ensure that substandard devices should be checked at point of entry into the country i.e. ports and not retail counters as many of these medical devices are billed to consumers by hospitals and not sold over a retail counter. It will protect consumers and domestic industry which is reeling under import of substandard low priced imports. There are instances of Chinese imports being claimed to be 'Made in India' medical devices.”
India imports around 80 per cent of its medical devices’ requirement and a fourth of that comes from the US. The overall medical devices market in the country is estimated to be Rs.640 billion.
It is learnt that MNC medical device manufacturers have expressed reservation over an increase in the font size of product details on packs as it is not affecting consumers in any way. They also sought clarity over the declaration of country of origin on the packs. For instance a manufacturer sourcing certain parts of the product from country A and assembling and packaging them in country B has found it difficult to comply with provision of amended rules related to declaration of country of origin on the product pack, said a patent lawyer handling MNCs on condition of anonymity.
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