Medical device makers may be exempted from packaging rules

The Department of Pharmaceuticals, which has reconstituted the National Medical Devices Promotion Council, will hold its first meeting on Wednesday. On the council’s agenda is discussion around “exemption of licensed manufacturers of medical devices from the Legal Metrology (Packaged Commodities) Rules, 2011”.

New Delhi, September 15, 2022: Licensed manufacturers of medical devices are likely to be exempted from the Legal Metrology (Packaged Commodities) Rules, 2011 that mandates that every package must bear the name, address, telephone number, email of persons or of office that can be contacted in case of consumer complaints.

The Department of Pharmaceuticals, which has reconstituted the National Medical Devices Promotion Council, will hold its first meeting on Wednesday. On the council’s agenda is discussion around “exemption of licensed manufacturers of medical devices from the Legal Metrology (Packaged Commodities) Rules, 2011”. The reconstitution comes after the Department for Promotion of Industry & Internal Trade (DPIIT) under the Ministry of Commerce and Industry, which was heading the Council from its inception, decided to hand over the onus. The meeting will be attended by representatives of industry associations and government officials. According to the reports published in economictimes.indiatimes.com

Rajiv Nath, forum coordinator, AiMeD said that patient safety should be paramount and the move of doing away with the packaging rules will only benefit importers.

“Many Importers have not been implementing the packaging rules and the provisions of the Legal Metrology Act & Consumers Protection Act as the enforcement mechanism has been weak on them while being stringent on Indian manufacturers. When manufactures export to the US , EU , Middle East we respect the laws of the land but the importers who don’t wish to be regulated seek exemption from application of these laws and rules under the garb of ease of doing business,” he said.

He said the department of consumer affairs and DoP need to enforce the law and rule book equitably and provide a level playing fieldand not get mislead by importers.

“Patient safety aspects under Drugs Act are complementary to consumer protection aspects of Legal Metrology Act,” he said.