Workshop on 'Use of International Non-proprietary Names in India'

The Centre for Trade and Development (Centad) organised a workshop on March 29, 2006 , with the objective of inviting various stakeholders to contribute inputs for a study carried out by Centad on the use of International Non-Proprietary Names (INNs) for pharmaceutical substances in India .

The event was attended by many experts such as officials from the World Health Organisation (WHO), the Drug Controller General of India (DCGI), trademark attorneys, representatives from pharmaceutical companies, public health activists, doctors, etc.

 The presentation by Centad highlighted various aspects of the study, beginning with a definition of the term ‘ INN '. The study examined the legal regime on INNs, both at the national as well as international level. However, the emphasis was on the World Health Assembly (WHA) Resolution 46.19 (hereinafter resolution), which calls for discouraging the use of INNs, particularly INN stems in drug brand names. The presentation also covered implementation of the resolution in India through various legal instruments and policy. It clearly explained lacunae in implementation. The presentation ended with an enumeration of suggestions to reform the regime.

The law and policy on INNs

INNs are internationally acceptable generic names for pharmaceutical substances that are proposed or recommended by the WHO with the aim of avoiding confusion in drug nomenclature and ensuring safety in drug use for the public. INNs are comprised of a unique fancy term along with a common stem. Common stems are the part of the INN that establishes the relationship between substances that have the same element in drugs. The uniqueness of an INN lies in its non-proprietary nature; therefore, the use of INNs in brand names would result in the appropriation of that name by the drug manufacturing company through a trademark.

This practice, it was argued, would create confusion in drug nomenclature thereby diluting the purpose of INNs. It was also pointed out that using stems in brand names impedes the creation of new INNs using the stem, as it enables a trademark owner to challenge the new INN .

WHA Resolution 46.19 encourages the use of INNs along with corporate names, to implement the objectives of the resolution. At the same time, the resolution is non-binding in nature (soft law) and does not create any monitoring or reporting mechanism to ensure compliance. The practice of issuing INN protection letters to national authorities is the only existing compliance mechanism available under the WHO-INN programme. Participants raised some questions on the effectiveness and exact nature of this mechanism.

With regard to domestic law and policy on the subject, the study explicated two relevant legislations -- the Drugs and Cosmetics Act and the Trade Marks Act 1999, as well as the National Pharmaceutical Policy. The relevance of Rule 96 of the Drugs and Cosmetic Act, and Section 13 of the Trade Marks Act in India , in relation to the use of generic names, was pointed out. While Rule 96 insists that the proper name of the drug (including the INN) be prominently printed on the label, the Trade Marks Act provides that the single name of a chemical element or compound shall not be registered as a trademark, and also that the words that the WHO has declared as an INN and is notified by the trademarks registrar shall not be registered as a trademark.

Despite the existence of substantive legal provisions prohibiting the registration of INNs as trademarks, the presentation pointed out that there are instances where trademark registration of names derived from INNs has occurred. Speakers highlighted instances of the WHO sending INN protection letters to the DCGI. They also said that their interaction with the DCGI had revealed that the DCGI normally sends a copy of the letter to the State Drugs Controller (SDC), the trademarks office, and pharmaceutical companies, to which the DCGI has received no response. It was also noted that instances of changing INN-based brand names have occurred in rare cases.

A list of instances where brand names have been derived from generic names, in India , was cited. It was felt that the frequency of using generic names in brand names depends on markets.

It was suggested that though the legal position on the use of generic names in India is clearly defined, there is fragmentation in the domestic regulatory regime. Instances of violation or misuse of the law in the Indian context were substantially enumerated.

Major gaps in implementation of law on INNs

• The non-binding nature of the WHA resolution, the absence of a compliance mechanism and lack of authoritative interpretation of the resolution.
• Lack of notification of the INN by the trademarks registrar, under Section 13 (b) of the 1999 Act.
• Lack of specific policy guidelines from the DCGI on the use of INNs in India .
• Lack of awareness about the public health implications among major stakeholders like industry, medical and legal professionals as well as trademark examiners in India .
• Lack of any requirement under the trademarks law to disclose the generic name of the pharmaceutical substance when applying for a trademark for the same.
• Lack of any notification of INNs by the trademarks registrar, as required under Section 13 (b) of the Trade Marks Act.

Suggestions

• There is the need for an international convention on the use of INNs.
• An effective mechanism for compliance with the requirements of Resolution 46.19 must be established.
• There is scope for better and informal coordination between the WHO and the trademarks office on the one hand, and between the Drug Controller General and the trademark office on the other.
• The DCGI should develop a system for national registration of all brand names under which drugs are marketed.
• The DCGI should develop policy guidelines on the use of INNs.
• Trademark applications for pharmaceutical substances should be accompanied by a disclosure of the generic name of the substance.
• INNs should be regularly notified, as required by Section 13 (b) of the Trade Marks Act.
• Trademark examiners should be sensitised to the public health aspects of INNs.
• The pharmaceutical industry, medical and legal professionals and other stakeholders should be sensitised to issues relating to the use of INNs.

Reviews of the study

Following the presentation of the study, a panel of experts presented their views on it. It was pointed out that from a consumer's point of view, the problem of proliferation of brand names and its impact on drug prices had not been examined in the report. The role of the WHO in giving generic names was also stressed as a point that needed more consideration in the report. Apprehensions were expressed regarding an instance where the INN is considered as an option and the innovator is given a chance to bypass the whole process of INN and get the brand name registered. It was also feared that in the present scenario, the WHO could not do anything if the manufacturer opts for a generic name that is unpronounceable or outrageous. The reviewers also dealt with consumer interest in the case of fixed-dose combination drugs, and said that the report had failed to look into the issue. It was pointed out that in the name of protecting the INN the basics of generic prescription should not be violated.

From a legal standpoint, the study's failure to address Section 9 of the Trade Marks Act was highlighted. There was a suggestion that the word ‘exclusively' be removed from Section 9, which talks about absolute grounds for registration that requires a distinctive character. It was also suggested that Section 13 be incorporated into Section 9 through a parliamentary amendment, for the resolution of existing questions on this Act. The review concluded by expressing a desire to change the trademark registration system altogether, as the present Act provides ample opportunity for trademark attorneys to register any generic name, even a name like ‘antiflu', which is highly descriptive.

From a regulatory perspective, the review discussed in detail the coining of brand names, their supposed utility and the increasing problem of using brand names. Creating awareness among consumers was suggested as one way of solving the problem of confusing brand names. As regards misbranding, the need to check the safety profile of drugs was emphasised. There was also the view that brand identities were getting lost nowadays.

The comments that followed the review session suggested the following:

• The need for an international treaty for uniformity, in spite of the intricacies that are involved in evolving an international convention.
• The report should include the implication of combination drugs and prescription practices by doctors.
• The legal consequences of the use of stems in brand names should be studied in greater detail.

Group discussions

The reviews were followed by informal group discussions. For this, the participants were divided into three groups.

Group I discussed the integrity of INNs and their importance in public health. It agreed on the following:

• To wholeheartedly support the use of INNs (generic names).
• The need to come up with rules regarding stem use, for the rational use of drugs.

Group II discussed the WHO resolution, its nature and suggestions. It agreed on:

• The need for a treaty in the long run that would help to consider country-specific problems.
• The need for informal coordination between the trademarks registry, the DCGI and the WHO.
• The need to take coherent steps to promote INNs and to stop pharmaceutical companies from sidestepping the emerging product patent regime.

Group III debated the law and policy of INNs in India , and arrived at the following conclusions:

• INNs are absolutely relevant to identify products and the diseases for which they are used/prescribed anywhere in the world.
• Stems can be used as part of a brand name because they will help identify the disease for which they are used or prescribed. Use of stems in brand names can be helpful for small companies.
• A centralised database may be maintained in the drug controller's office to verify whether a licence had already been granted under the same name to a third party.
• The trademarks registrar should periodically be provided with a list of INNs to prevent their registration thereof as brand names.

The discussion concluded that INNs are extremely relevant in India . Their use should be encouraged, although there is the possibility of deception or confusion. The DCGI has a role to play in this regard, apart from the trademarks office. The need of the hour is better coordination between the DCGI's office and the trademarks office.

Concluding remarks and observations

The concluding session of the workshop consolidated the views on INNs, with interesting observations on the use of INN stems from a panel including the DCGI, WHO officials and legal experts representing the major agencies involved in the debate on INNs.

The DCGI complemented the WHO and Centad for initiating a serious discussion on INNs on a wider platform whereby all parties concerned could be sensitised to the issue. Despite constraints in the regulatory environment, the drug controller's office is engaged in promoting the use of generic names and has instructed the trademarks office to prevent the use of INN stems in trademarks.

The DCGI pointed out that there were several constraints in the regulation of brand names in India . This problem is further complicated by the large number of pharmaceutical companies in the country. Brand names cannot be restricted legally. However, the use of a stem or a part of it while coining a brand name gives an indication of the generic name of the drug thereby indirectly promoting its generic use.

It was observed that the attribution of a stem to a brand increases the substitution value of the drug and reduces its brand value, indirectly deferring the benefit of using INN stems in the industry. Setting aside commercial interests, one of the major concerns about permitting the use of stems would be to facilitate consumer awareness through a common stem.

In view of the diverse views held by participants on the use of INNs, particularly the views of some civil society organisations that there could be benefits for consumers if the use of INN stems was allowed with some caveats for coining brand names, it was acknowledged, on behalf of the WHO, that this concern may be given appropriate consideration. The participants did not reach any definite conclusion on this point but agreed that there was a need to examine the issue further.

The open forum that followed came up with the proposition that immediate action from all the concerned authorities was necessary. It concluded the discussion with the following suggestions:

• At the international level, there is a need to devise an international convention on INNs.
• There is a need for the WHO to devise a mechanism to monitor the implementation of the resolution in relation to INNs.
• At the national level, better coordination and an organic relationship between the DCGI and the trademarks office is needed.
• The issue of brand approval has to be resolved through a new policy drawn up by a Central Drug Control Authority.
• The trademarks office should maintain a list of INNs and crosscheck with the list before granting trademarks.
• Specialised examiners should be placed at the trademarks registry to deal with pharmaceutical trademarks.
• Adequate representation from medical professionals in the debate on INNs is called for.
• A national policy guideline on the use of INNs is urgently needed.
• The trademarks office should regularly notify INNs in the prescribed manner.
• Applications for trademark registration with respect to pharmaceutical substances should disclose the generic name of the substance.

View press reports on the workshop:
Control on use of INN in drug brand names likely, WHO identifies 80 such products
Pharmabiz (April 7, 2006)