The year 2016 opens with some great promises for the pharma and medical devices industries in India. The promises come with a slew of ground-breaking initiatives on the part of policy makers to ensure hassle-free growth across the sector. The government looks all set to remove even the last policy bottleneck that could come in the way of these rapidly expanding industries.

In a significant announcement made in December last year, the authorities said the government was in the works to create a new ministry dedicated to the pharma and medical devices industries.

India’s complex drug regulatory mechanism involves different agencies operating under multiple ministries to deal with various aspects of regulation. For instance, if manufacturing quality is governed by the health ministry, the pricing of medicines is controlled by the chemicals ministry, whereas, the ministry of commerce and industry is responsible for setting standards for foreign trade, exports and so on. In effect, a manufacturer having full-fledged operations may have to approach all of them one by one, leading to inordinate delays.

The proposed ministry is expected to integrate these functions under one roof. Such a measure would, undoubtedly, be immensely beneficial for the drug and device makers who are frustrated running pillar to post to get things done. However, how easily the powers vested with different centers could be brought together remains to a question. Anyhow, the government is very clear about the plan.  
  
“I assure you in next one year it will emerge as a separate entity as pharma and medical devices ministry,” said Ananth Kumar, minister for chemicals and fertiliser, government of India.

Delinking Devices
In a related but other major move, the government has decided to delink regulation of medical devices from pharmaceuticals, in response to a long-standing plea from the device makers. At present, there is no separate rule book for medical devices in India and they are regulated alongside drug products applying the same set of rules.

Device makers argue that the existing pharma-oriented regulatory structure has been proving detrimental to the growth of domestic manufacturing as devices have altogether different R&D, technologies, investment, production and taxation requirements. As the market for devices grew divergent, the rudimentary regulatory apparatus resulted in high import dependency.

Currently, India’s nearly $10 billion med devices market imports more than 70% of devices for domestic use, according to Association of Indian Medical Device Industry (AIMED). Lack of a well-formed regulatory framework discourages potential investors too.

Now the health ministry has begun the process of widening the scope of the regulations pertaining to medical devices by proposing necessary changes in Schedule MIII of GMP in India’s Drugs & Cosmetics Rules 1945. The draft has already been circulated among the stakeholders for their feedback. The revised schedule would be issued for public comments before forwarding it to the law ministry for amending the D&C rules.

AIMED welcomed the decision to dissociate devices from drugs hailing it as first step to address the ambiguity.

Regaining API Glory
Again, the government promises to announce a comprehensive plan to infuse a fresh dose of vigor into the country’s API sector. In recent years, the industry has witnessed several API makers, especially small to medium players, withdraw from the scene as they find it unable to sustain operations due to intense competition in the pricing front and import surge. The government declared 2015 as The Year of Bulk Drugs early last year and set up an expert committee to map out strategies to make India self-reliant on APIs.
The expert committee, headed by Dr. V M Katoch, former secretary, Health Research, recommends measures like revival of public sector production units, creation of govt-sponsored mega parks with common facilities for effluent treatment, testing, captive power, etc. It also proposes tax-free status and concessions in duties and tariffs for cluster developers to promote desi production and reduce dependency on imports. To attract foreign investments the panel suggests an effective mechanism for faster clearance.

According to officials from the department of pharmaceuticals under the ministry of chemicals and fertilizers the national bulk drugs policy is already in the final stages and will be unveiled in this fiscal year.

While the med device makers look forward to the creation of a sought-after manufacturing hub for low-cost devices, India’s API industry hopes to regain its glory once lost.