Another regulatory medicine needed

In late 2005, Bombay High Court’s then Chief Justice was surprised when informed that pace-makers and stents were not put through a regulatory approval process before they were sold in the country.

The Court hearing was to do with the use of stents (wire-like devices inserted into blood vessels to remove blockages). The Court proceeded to instruct the Central and State drug regulators to formulate laws for medical devices.

That, in a sense, kick-started the process of regulating medical devices — ranging from the humble surgical glove, cotton or syrup spoons to critical cancer imaging-equipment such as MRI machines, heart-valves, eye implants and drug-coated stents, to name just a few of the 2,000-odd devices estimated to be sold in the country.  

The process of regulating this segment started with a handful of devices being brought under the existing Drugs and Cosmetics Act (1940). And after a slow journey, it has finally arrived at the Drugs and Cosmetics (Amendment) Bill 2013 (D&C), recently placed in the Rajya Sabha.

 The Bill, if and when eventually passed, will be reborn as the D&C (Amendment) Act 2013, and will regulate drugs, cosmetics and medical devices.

There is no arguing that a framework to regulate products inserted into our hearts, eyes, etc., is long overdue. But the last mile in finalising the proposed law has the medical technology industry worried. Medical devices should not be viewed through the same lens as drugs (their more high-profile counterpart), med-tech representatives point out.  

It may seem obvious that a medical device is not a drug. But the popularity overhang of big brother pharma has in the past led to the drug regulator dealing the same hand to both sections of the healthcare sector – despite med-tech having its own set of requirements and peculiarities.

The recent draft does outline the approval, inspection, and trial processes for medical devices. But details beg clarity, and the Government needs to watch out from having virtually no laws for med-tech to doing an overkill on a segment still taking baby steps. 

Chemistry vs engineering

If medical devices are viewed through the same prism as drugs, it will be like using the wrong weapon to get the job done, says Rajiv Nath of the Association of Indian Medical Device Industry.

Explaining the difference, Nath says medicines are about chemistry and they are evaluated on parameters such as efficacy and quality.

Medical devices are about performance, engineering — evaluation of how a device works in relation to another competing product, the skill of the user, etc. It involves not just industry, but doctors and consumers too, he says, adding that the Government should have taken inputs from more stakeholders before drafting the proposed law. His view resonates with people who run their own med-tech business, across the country.

There should be a separate department for medical devices with people tuned to the technical needs of the sector, says G.S.K Velu, founder of Chennai-based Trivitron Healthcare. And the role of the regulator should be different from the authority tasked with promoting the industry, he adds.

A similar structure is seen in the pharmaceuticals segment, for instance, where the Drug Controller’s office regulates the industry while the Department of Pharmaceuticals supports growth initiatives of the sector.

Local innovation and growth need to be encouraged, says Velu. In China, for example, there are 20 companies with a market-capitalisation of more than $1 billion, he points out. 

The Indian med-tech market is estimated at Rs 25,000 crore, and of this only about Rs 7,500 crore comes from domestic companies (the rest is imported). Of the domestic company revenues, about Rs 2,500 crore is from exports, says Nath. 

That possibly explains why consumers may not remember local medical device brands or companies, despite being familiar with multinationals such as Philips or GE. A cheerless picture, given that the country is estimated to have about 700 manufacturers of medical devices.

Dispovan syringes, from Hindustan Syringes & Medical Devices (HMD), for example, may be among the few local med-tech makers that enjoys some visibility. But tucked away in a “tiny town” called Shahjahanpur (Uttar Pradesh) is another company, Surgiwear.

For a little-known company, its homepage says, “almost 1/4th population of the world is treated with Hydrocephalus Shunt manufactured by Surgiwear.”

A shunt, in this case, helps drain excess fluid from the brain into the abdomen, explains G.D. Agrawal, Surgiwear founder. Shunts are a flagship product of this implants-maker. 

But it requires three different approvals from the Centre and State to make a product and this is time-consuming, he says, adding that it becomes easier to import a product than make it locally. Patients suffer too, he says, as products made locally are about one-tenth the global price. Up against several odds, local manufacturers say that the Government’s myopic vision has resulted in an environment that does not allow them to “grow and bloom.”

Penalty and punishment

The new Bill envisages a Central Drug Authority (CDA) where drugs, cosmetics and medical devices will have different arms governing them.

But with the Health Ministry already facing flak on clinical testing of medicines in human beings, some of that heat is getting passed on to medical devices too, fear industry representatives.

Whether the company is multinational or Indian, no one wants to make a mistake, says Vibhav Garg,  representing AdvaMed (Advanced Medical Technology Association), a trade body for multinational companies.

The proposed law looks at industry “like everyone is a criminal”, he says.

Punishment and penalties should be progressive, from mild to major violations, he reasons. 

 In fact, says Nath, medical devices vary from reading glasses to critical devices such as pace-makers, and implants in the eyes, knees and so on. And that is how they are graded, from negligible risk products like a spoon for a cough syrup, to medium and moderate risk, to the actual high-risk products, he explains.

But the proposed law appears to slip into the drugs-mode when it outlines violations. For instance, it seeks clinical trials of new products in a manner reminiscent of drugs.

In med-tech, there is constant feedback from doctors and for every innovation or recommendation, it would be difficult to go through a long process of ethics committees or CDA approvals, Nath points out, stressing the need for flexibility and graded assessment of technology innovations.

The severity injected into the proposed law makes prison a very imminent possibility for violations, he says, adding that it is difficult for the industry to work with a sword over its head. 

The idea is not to dilute quality, performance or safety criteria for medical devices but to bring them in tune with the science involved in medical technology.

And since medical devices are ubiquitous in our lives, the Government needs to initiate discussions with industry, doctors and patient-groups even before charting the final course on this critical healthcare segment.

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