Even as Indian drug-makers have heaved a sigh of relief with the United States’ decision to shelve the plan to extend the tariff hikes to generic medicines, a key change is in the offing in domestic regulations that will spell trouble for them.
The country’s drug regulator has proposed to close the easy route for pharmaceutical companies to quickly launch generic versions of “new drugs,” by just proving that the generic versions are bio-equivalent to the innovators’ drugs.
Experts said that the move has come in the wake of growing pressure from the Donald Trump administration to reduce the non-tariff barriers for US companies in India.
If the proposal made in a “note for public comments” released by the Central Drugs Standard Control Organisation (CDSCO) is converted to a rule, launch of generic drugs will also require submission of separate data on clinical trials, just as the “new drugs” do. Clinical trials are much more expensive and time-consuming than the bioequivalence studies.
Currently, once a new drug is approved based on clinical trials and BE data, the generic companies simultaneously submit the BE study report with the regulator, and obtain approval for their version of the drug.
However, this puts the innovator company in a disadvantageous position as there is a lack of level playing field, the CDSCO said in the note.
As per the Indian regulations, a drug is considered “new” from a period of four years of its marketing approval granted by the CDSCO. During that four-year period, however, another company can launch a generic version through the “subsequent new drug” approval pathway which requires submission of BE data.
The CDSCO note acknowledged that the cost of regulatory compliance is “much lesser” for generic drugs as they are not required to conduct the clinical trials. “In order to remove the discrepancy and to encourage the development of new drugs, it has been decided to deliberate the matter in consultation with the stakeholders and the concerned departments for taking appropriate decisions,” the note said.
“The CDSCO after reviewing such (generic) applications in consultations with SEC (subject expert committee) grant permission to conduct the clinical trials & bioequivalence study with the new drug to multiple applicants.
In many such cases, it has been observed that only one applicant actively conducts both clinical trials and the bioequivalence study with the new drug and submit the reports to CDSCO for its approval. Once the new drug is approved for the first applicant based on clinical trials and bioequivalence study data, the other applicants (generics) simultaneously submit the BE study report and obtain approval for the same new drug as subsequent application,” the note said.
“Nearly all the Indian drug companies will be affected if the government intervenes with stricter requirements to launch a subsequent new drug. Further, the US has been mounting pressure on India to look into some of these non-tariff barriers faced by the US firms operating in India,” said a pharma consultant.
According to sector experts, while the proposal in the CDSCO note looks problematic for the generic industry, there’s a possibility that the government might permit generic companies to take subsequent new drug routes requiring only BE studies for approval only two-three years after the first applicant’s drug hit the market . “If that happens, this could give regulatory data exclusivity for a limited time to foreign firms to launch multiple new drugs in the country,” said Anay Shukla, founding partner at Arogya Legal.
The multinational firms, which have a bigger presence in the novel drugs segments, have been pushing for data exclusivity to protect their clinical trial data. Data exclusively is denied in India as it is feared that it will make “ever-greening” of patents easier, besides circumscribing the generic industry. The additional burden on the generic firms – in the form of mandating them to conduct their own clinical trials or putting restrictions on BE studies – could delay the launches of generic versions of new drugs and even potentially increase the prices.
Meanwhile, the CDSCO note has said that stakeholder feedback will help in formulating a “balanced policy” to ensure level playing field in new drug approval while fostering research and development of new drugs in the country.