India's regulator is to enforce a deadline for drug launches within six months of new drugs obtaining marketing approval. This is part of a greater move to enforce safety and efficacy monitoring regulations.
IHS Global Insight perspective | |
Significance | The Drug Controller General of India has written to state drug regulators in an attempt to enforce existing post-marketing surveillance activities for new drugs within the Indian market. |
Implications | The provisions will see companies' marketing approval deemed "cancelled" should companies fail to launch their products in the Indian market within six months of obtaining marketing approval from the Central Drugs Standards Control Organization. |
Outlook | It remains unclear how many companies will be directly affected by the move, but the measure is unlikely to be welcomed by international companies, who may delay submitting drug applications until they feel they have a strong enough marketing/sales potential within the country. |
The Drug Controller General of India (DCGI), Dr G.N. Singh, has recently sent a letter to all state drug controllers reaffirming the commitment of the Central Drug Standards Control Organization (CDSCO) to enforce Periodic Safety Update Reports (PSURs) and laying down punishments for firms that do not comply with set regulations. The PSURs are already enshrined in law under the Drugs and Cosmetics Act of 1945. A copy of the letter can be seen here.
Under current Indian law, pharmaceutical companies are mandated to provide safety and efficacy reviews for new drugs through PSURs. These reports must be submitted to the DCGI/CDSCO every six months for a period of two years following an Indian marketing approval from the CDSCO. Following this period, PSURs must be submitted annually for a further two years. After the four-year period, drugs are no longer considered new and are no longer subject to post-marketing surveillance activities.
Within the letter from the DCGI, concerns were raised that a number of companies were not conducting relevant PSUR activities. The DCGI went on to suggest that a number of companies were also choosing to not launch their drugs for certain periods following their marketing approval in order to avoid conducting PSURs. This, the DCGI believed, was allowing the companies to market products within the Indian market without adequately establishing drug efficacy and safety. The DCGI did not highlight specific companies he believed had used this "loophole".
In order to close this loophole within the Drugs and Cosmetics Act, the DCGI has laid down some provisions that would penalise companies attempting to use this route for market entry. Under the new provisions, companies that do not launch their product within six months of marketing approval will see their marketing licence deemed "cancelled". This provision does not appears to be new legislation but more a clarification of the DCGI's interpretation of the Indian Drugs and Cosmetics Act.
Outlook and implications
Despite the clarification of the legal situation, there remain a number of areas where the law could be considered to remain unclear. First, it remains unclear whether products for which marketing approval is deemed to be cancelled will be required to submit a full New Drug Application. In addition, it remains somewhat unclear as to what action will be taken if a company launches a product in India but fails to submit a PSUR, or what the DCGI considers to be adequate PSUR activities.
Indian authorities have previously allowed companies to conduct post-marketing Phase IV clinical trials where companies are unable to conduct Phase III trials. This happened for Dr. Reddy's biosimilar product Reditux (rituximab), for which the CDSCO allowed Dr. Reddy's to conduct Phase IV trials because there were insufficient patients using the reference product – Roche's MabThera/Rituxan (rituximab) – for Dr. Reddy's to conduct a Phase III trial.
It is not known how many companies will be affected by the closing of the loophole. The move is likely to be widely unwelcomed by both domestic and international pharmaceutical companies working in India, however, due in part to the added cost of conducting post-marketing surveillance activities. In addition, the provision may cause companies to delay seeking a marketing authorisation as they attempt to consolidate their marketing and sales presence before product submission in order that they can "hit the ground running" once they have received approval. The DCGI is seemingly ignoring the fact that many companies may legitimately delay product launch in India until they have a sales, marketing, and distribution presence in the country or have located a partner with these capabilities.
Despite having reservations over the closure of the loophole, companies may choose not to voice their concerns publicly as they may wish to keep a low profile following the continued media coverage of deaths occurring during clinical trials (see India: 14 January 2013: Reports of rise in clinical trial deaths in India). This coverage, and subsequent criticism of the CDSCO from the Indian Supreme Court, has prompted the DCGI and CDSCO to consider alterations to the Indian drug regulatory environment (see India: 7 January 2013: Indian government to set new rules governing clinical trials and India: 3 January 2013: Indian Supreme Court hands health secretary temporary control of clinical trials). IHS Global Insight therefore expects that further regulations are likely to appear within the coming months; however, with the international pharmaceutical companies feeling increasingly hounded over this and a number of unfavourable patent rulings (see India: 14 January 2013: India mulls issuing compulsory licences for three oncology drugs), the Indian government must tread carefully as it walks the thin line between regulating and alienating pharmaceutical companies.