India Considers Separating Device Regulations From Drugs

India’s government is mulling a decision that would regulate medical devices separately from pharmaceuticals, in a move that could pave the way for greater investment and research and development in the country, an industry group says.

The Heath Ministry will soon solicit public input via the Central Drugs Standard Control Organization’s website on proposed changes to the Drugs & Cosmetics Rules through the law ministry, says Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry.

The announcement follows a meeting held Dec. 5 between senior officials with the Health Ministry, the Indian government, CDSCO and industry stakeholders, including AIMED. The Health Ministry has prepared a draft proposal and circulated it to industry associations to provide feedback by Dec. 14, according to meeting minutes released by CDSCO.

Vince Suneja, CEO of TwoFour Insight Group, says this development could be significant if it actually happens.

“There is already a pending amendment to the Drugs & Cosmetics Act, which would give this separation a statutory basis versus what is being proposed here under the Drugs & Cosmetics Rules,” he tells IDDM. The legal authority is greater with the statute versus the rules.

But the amendment to the Drugs & Cosmetic Act of 1940, which has been tabled in the Parliament, is “half-hearted,” Nath says, adding devices need separate rules, and either a separate regulatory authority or a revamped CDSCO as an Indian Healthcare Products Regulatory Authority.

AIMED welcomed the Indian government’s initial but firm steps to address this issue.

“Indian medical devices have for long been incorrectly and incompletely regulated,” says Nath. The lack of an internationally equivalent regulatory framework has been confusing to overseas and Indian investors who were scared to invest with pharmaceutical type GMP demands being imposed by regulators in an arbitrary and prescriptive manner by unsure inspectors on an engineering industry, he adds.

Currently, India is dependent on imports for 70 percent of its devices, and the size of the market is estimated to be more than $10 billion in terms of retail level sales (IDDM, Nov. 13).

AIMED has been seeking changes in the Drug Rules covering regulatory quality management framework and infrastructure requirements on the lines of the Bureau of Indian Standards and International ISO 13485 standard for regulatory purposes, says Nath.

AIMED hopes India will adopt a risk proportionate regulatory framework, giving lower compliance requirements for low-risk devices like wheelchairs and moderate-risk devices like needles, and higher requirements for high-risk devices, such as orthopedic implants and cardiac stents, Nath says.

He also wants to see the unbundling of regulations and regulatory controls, so that regulators would delegate the task of compliance audits of manufacturers to third-party assessment and certification bodies.

“In India, there has been no onus on manufacturers to demonstrate compliance,” says Anil Jauhri, CEO of the National Accreditation Board for Certification Bodies. “There is a need to provide this layer whereby manufacturers voluntarily use accredited third party conformity assessment bodies to verify and certify their compliance level to regulations.”

Earlier this year, the Indian government announced the creation of a dedicated authority to oversee the regulation and production of medical devices (IDDM, July 10). — Jonathon Shacat