New Delhi|HL
New biosimilar guidelines will soon set to n July by government for the approval of biosimilar drugs.
Biosimilar drugs are copies of complex products based on living cells. The country’s biosimilar guidelines were first unveiled in 2012.
“These revised guidelines (on similar biologics 2016), expected in the first week of July, will not deviate much from the draft released earlier in March,” a senior health ministry official who did not wish to be identified told ET.
At the same time, the final revised guidelines clarify parts of the draft that could have been interpreted in more ways than one, the official said.
The ministry expects the final guidelines to uphold the safety and efficacy of biosimilar drugs hitting the Indian market through stringent requirements, according to the official.
For instance, the guidelines mandate that no less than 100 patients be used in certain clinical trial phases, the official said. “Some countries allow less number of patients in such trials than we will,” the official said.
The guidelines also specify the conditions that biosimilar makers need to meet to exempt themselves from certain clinical trials, the official said.
The proposed changes in the draft guidelines, which could more than halve the approval time for biosimilars here, had earlier met with concerns from multinational pharmaceutical companies. The Organisation of Pharmaceutical Producers of India (OPPI), a lobby group of MNC drug companies, had then suggested that the draft diluted requirements in the 2012 guidelines which could compromise patient safety.
The latest revisions come amid questions from global drug makers like Swiss biotech giant Roche, which dragged the government to court over the process followed for approvals of a few such drugs.
The Swiss drug maker recently sued the Drugs Controller General of India (DCGI) to block approvals for Hyderabad-based Hetero Drugs’ ‘biosimilar’ of its blockbuster cancer drug, Avastin (bevacizumab).
Roche challenged the process followed by a health ministry Subject Expert Committee (SEC) to recommend the drug as a copy for use in metatastic colorectal cancer even while Hetero skipped some phases of clinical trials.
The company had also taken biotech drug makers Biocon, Mylan and Reliance Life Sciences to court over their biosimilars of its breast cancer drug Herclon (trastuzumab).
The Delhi High Court subsequently imposed conditions on their copies of trastuzumab — a move frowned upon by health activists who argued that it would affect the availability and affordability of the expensive treatment
