Drug Regulation

The DCGI is preparing a document to implement the patent-registration linkage system

Readers may remember that SpicyIP had recently carried an extensive post in regards the ‘Patent-Registration’ linkage system that was proposed by the DGCI. Pharmabiz.com reported a couple of days ago that the DCGI is preparing a document outlining a system to implement the linkage system. Once the document is ready the DCGI has promised to make it available to the industry for debate and discussion to ensure that everybody’s interests are protected. The pharmabiz.com report also informs us that the Central Drugs Standard Control Organization (CDSCO) has embarked on an ambitious e-governance project to digitize all their records in a bid to ensure better co-ordination amongst their various offices. Their stated aim is to ensure better accountability and transparency.

At this stage SpicyIP must once again reiterate what it has previously stated: this proposal will only delay the entry of drugs into the market since the DCGI is going to increase the workload of the already severely burdened Patent Office.

We have one further observation to make as to why this proposal is not keeping with the policy behind the Indian Patent Act: This proposal destroys the very raison d’etre of the Indian Bolar provision (S.107A of the Patent Act). The Bolar provision allows generic drug manufacturers to manufacture, use & sell a patented drug for the purposes of submission of information required under any law for the time being in force. Basically this means that Cipla can manufacture and test Roche’s patented drug for the purpose of gaining regulatory approval from the DCGI. Section 107A was introduced for ONLY this purpose of facilitating faster regulatory approval. The Parliamentary intent behind this provision of law was clear – it was to ensure that the generic drugs could enter the market as fast as possible by gaining regulatory approval from the DCGI even before the patent expired. Therefore once the patent expired instead of waiting for the DCGI to grant approval the generic manufacturer could introduce his drug directly into the market since he would have already got the necessary approvals.

For our previous post on this topic please click here. Below is the relevant portion of the Pharmabiz.com report:

DCGI preparing document to bring in system for patent linkage

May 24, 2008, 0800 IST

The Drugs Controller General of India‘s (DCGI’s) office is preparing a document in a bid to lay down a system to follow while granting marketing approvals. The step is to address the issue of patent linkage between the drug regulatory authority and the Indian patent office.

Once prepared, the document will be made available for the industry for discussion and the authority will ensure protection of interests of the pharmaceutical industry, according to Dr Surinder Singh, DCGI. The document is expected to address the hot issues related to the non linkage between the DCGI’s office and the patent office, which has much concerned the foreign innovator companies and the Indian generic companies.

Delivering key note address in a seminar, ‘How Quality Pays’, conducted by Indian Drug Manufacturers’ Association (IDMA), the DCGI said that the Indian pharmaceutical industry is going through a changing scenario and has to meet various challenges. The linkage between patent office and drug regulatory office is one among them which does not have a system to solve mutually at present.

“We should consider that the Indian pharma industry has come a long way ahead over the past few years and the companies were using the patent advantage for generic growth. The document we are preparing, will address the issue with patent office without compromising the interest of the Indian companies and the public,” he averred.

The Central Drugs Standard Control Organization (CDSCO) is currently, developing a system for its operations and the primary focus is to bring in Standard Operation Procedures (SOPs), guidance documents and specific time frame for clearance of files. In order to modernise the operations of the organisation, an e-governance project has been designed. With this, the records in the drug regulatory system will be digitalised and an interactive portal will be launched for better communication between the organisation and the industry players from various parts of the country, said Dr Singh.”The e-governance method will ensure transparency and accountability in the regulatory system. With our stronghold in IT, the people will be trained to get their needs done from CDSCO using the e-governance,” he maintained. He also added that the industry should come forward to communicate its complaints, suggestions and ideas with the drug control mechanism in future.

Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).


  1. AvatarAnonymous


    A valid observation by you this time…
    Any hold-up by DCGI would go against s. 107.

    But I have a feeling that this would be rectified by DCGI..
    Do note that DCGI has said that they will ask for Industry comments and I am sure that Companies will ask the form to be modified in such a manner that linkage be in such a manner that license format be modified for test v/s sell or manufacture purposes.


  2. AvatarSy


    I don’t think such a move of linking drug approval to patent system will be of much use the way we are getting the feelers from DCGI. Let us wait until DCGI put forth a draft proposal for such a move. But for the time being I could not stop myself from offering some of my views.

    If such a provision is put into place, this will indirectly extend the life of patent protection for some more time(because regulatory approval after patent expiry does not happen overnight, if the molecular is complex, as in case of biosimilars it may even take few years). This will only be a fraud on public since the fruits of patent are not available to people at large soon after the expiry of patent. The patentee is getting much more than what he is guaranteed by the patent act.

    This does not mean that DCGI and patent office should not work together. There are areas both of them can coordinate each other, for example:

    We know that pharma and biotech patents are filed at much earlier stages than their commercialization. Most of the time is used up in regulatory approval. On an average about 40% to 50% of the patent life is already over by the time a pharmaceutical or biotech drug comes to market. Until the phase III results are out there is no guarantee that the drug will do well. With such a risk involved, it would be better if a provision to extend patent life for innovative pharma or biotech drug is brought about if regulatory approval is taking more time than expected. This will help the Indian pharma and biotech industry, who presently is relying on doing generics or biosimilars and hardly any innovative research. If such a provision is brought about I am sure there will be increased spending on R&D activity and more innovative products will come out. Such a practice is already in place in US and European countries.


  3. AvatarPrashant Reddy

    Dear Anon,

    I’m not too familiar with the approvals required by the DCGI. I was under the impression that the only approval they give is marketing approval. Therefore if a generic manufacturer tests a patented drug and submitted the information to the DCGI under Section 107A then the DCGI has to give them marketing approval. Or are there different approvals for testing, selling and manufacturing? Could you please explain your point in context of the example that I have used. Looking forward to reading you response.

    Warm Regards


Leave a Reply

Your email address will not be published.