The Drugs and Cosmetics (Amendment) Bill, 2013, introduced in the Rajya Sabha recently, aims to bring about sweeping changes to the way drugs are regulated in India. It makes an effort to tackle the problem of spurious drugs — an effort that has been praised widely. But in attempting to centralise the process of issuing licences to many key drugs, the bill seems to have stirred a hornet’s nest in the drug industry.
One of the main features of the bill is that many new drugs will be re-classified once it is passed into law. Most crucially, though, medical devices will now be classified as drugs and therefore, will come in the ambit of this bill. The new definition (detailed under Section 6, sub-section xi) defines them as, “any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software, intended by its manufacturer to be used specifically for human beings or animals” to conduct diagnosis, monitoring, treatment, or alleviation of any disease or injury, supporting a person’s life, or for modifying or supporting any anatomical or physiological process.
Medical devices could be anything from a surgeon’s gloves to stents to MRI machines, implants, and almost every other tool used by the medical industry. Under the current law, there is no regulatory process that approves or disapproves of the standards of a medical device before it is sold, barring the quality assurance guidelines established by the company making it. Hospitals sometimes prefer to import medical devices since imported devices have been vetted by government agencies (such as the Food and Drug Administration in the US), but these tend to cost more.
“This move was long overdue,” says Subhatosh Majumdar, a Calcutta-based patent lawyer who specialises in drugs and medical litigation. “The medical devices industry has been seeking regulation for years to build credibility both among doctors at home and foreign clients. Regulation will also ensure that minimum quality standards are met,” he says.
But others say the bill has not thought through this initiative. Says Rajiv Nath, forum co-ordinator, Association of Indian Medical Device Industry, “The government is trying to say that medical devices are different from drugs, but the bill only sees devices through the prism of drugs.”
The main problem here concerns “adulterated” medical devices, says Nath. In chapter IIA of the bill (which contains guidelines for the import, export, manufacture, distribution and sales of medical devices), an adulterated medical device is defined as any device that is composed of in any measure “rusted or corroded or filthy or putrid or decomposed substance”, packed under unsanitary conditions that would make it hazardous to someone’s health, contains toxic substances, and so on. On paper, this sounds reasonable. However, the bill puts the onus for an adulterated medical device entirely on the manufacturer. “So even if a user stores a device improperly, it’s the manufacturers who will be held liable,” says Nath.
That’s not all. The bill talks about minimum standards for medical devices, but doesn’t actually define what these standards are. Also, says Nath, measuring the efficacy of medical devices is simply not feasible. “These devices are pieces of science and engineering,” he explains. “You can measure the efficacy of drugs, but not of a medical device. The government should measure their performance. Drugs and medical devices are two completely separate things. You can’t measure them with the same indicators.”
The bill also seeks to set up a Central Drug Authority (CDA), which will regulate and issue licences to 17 critical drug categories (which includes vaccines, blood products and antibiotics). These also comprise a major portion of the drugs manufactured in India. Currently, state bodies have the authority to issue licences to manufacturers for all drug types, including these 17 categories.
The CDA replaces the existing Central Drugs Standards Control Organisation (CDSCO) which, though a central body, does not have too many regulatory powers. In fact, in 2003, the Dr Mashelkar parliamentary expert committee on a comprehensive examination of drug regulatory issues had noted that the creation of something like the CDA would be pointless, and instead recommended that the CDSCO be made autonomous and better equipped.
Needless to say, the drugs industry is quite miffed with the move to centralise the regulation and licensing of key drugs. But there are voices in the industry that have welcomed the move, especially if it checks the sale of spurious drugs. Says Jason D’Souza, head of corporate communications for Glenmark Pharmaceuticals Limited, “The key thing to remember here is that India’s pharmaceutical industry is the second largest in the world, right behind the US. Many companies here market to clients at home and abroad, and we need to meet standards that appeal to both. This bill is plugging loopholes.”
Not everyone agrees with this view. Ravi Uday Bhaskar, general secretary of the All India Drugs Control Officers’ Confederation, argues that India is a huge country and one central authority may not be able to cover the entire country adequately. “The proposal is neither desirable nor feasible if we look at the legal and logistic issues,” he says. “The solution lies in building competence in the state drugs control organisations by enhancing the technical, managerial, legal and investigation skills of the officers through scientifically designed training programmes,” he asserts.
In fact, with centralisation, complications could arise in the manufacture, sale and distribution of common drugs, points out Bhaskar. “For example, to export a simple drug like Paracetamol one will need permission from the Centre,” he says.
Clearly, stakeholders are divided in their opinion on the bill. The ball is now in the government’s court and it would do well to take into account some of the concerns regarding the bill so as to usher in a streamlined drug regulatory policy in the country.