Even as the drug regulator of the country has withdrawn an alert on ophthalmic use of its cancer drug Avastin (bevacizumab), the Swiss pharma major Hoffman-La Roche says that the medicine has neither been developed nor manufactured according to the quality standards for drugs to be injected into the eye. It will continue to spread awareness among the physicians about the known risks associated with the off-label use of Avastin in the eye, said the company. Off-label use is the use of a medicine for an therapeutic indication for which the originator company has not sought approval from the regulatory authorities, but has been proven by repeated use by the practitioners, said experts.
Read more from our special coverage on "AVASTIN, ROCHE"
"Roche respects the recommendations of the DCGI and the right of physicians to make decisions regarding treatments. To ensure that physicians are able to make these decisions with a full awareness of the evidence, we will continue to make them aware of the known risks associated with the off-label use of Avastin (bevacizumab) in the eye. This includes alerting them to the fact that Avastin (bevacizumab) has neither been developed nor manufactured according to the quality standards for drugs to be injected into the eye," said the company. The company was responding to queries from Business Standard on the recent notice of Drug Controller General [India] (DCGI), withdrawing its earlier alert against off label use of the drug to treat certain ophthalmic conditions and directing the physicians' organisation to prepare a guideline for the usage.
The company added that Avastin has not been approved for use in the eye by the US Food and Drug Administration, European Medicines Agency or the Government of India. It is not developed and manufactured to meet intraocular standards and adaptation of the product for use in this way is considered 'off label'. "Our recommendation is that Avastin should be used in line with the approved prescribing information," said the company.
Responding to a query on whether the company has conducted any study on the impact of bevacizumab injection for age-related macular degeneration (ARMD) and other such indications, Roche commented that it strongly believe that a development programme for Avastin for intraocular use would not offer added medical benefit over the products that are already approved.
"Roche believes it is in the best interests of patients to continue to focus our efforts in ophthalmology on discovering and developing new potential medicines for other serious diseases of the eye for which safe and effective therapies are not currently available," it added.
The company has provided the DCGI with a list of authorised distributors for Avastin and it is also working with health authorities to put in place a mechanism to track the authenticity of its products, added the company.
The DCGI, on January 21, this year, has issued an alert notice as a precautionary measure in the light of the incidences of blindness reported in Gujarat following the use of medicine allegedly for Ophthalmic conditions.
According to reports, the injections has damaged the vision of 15 patients in Gujarat, following which the State drug control office put its sales on hold. The expert committee was formed to look into the issue and it has submitted its report on February 8, 2016.
The committee observed that the safety and efficacy of the medicine in its use intravitreal (inside the eye) has been proven in over 2,500 independent studies published globally and that it is 40 times cheaper than the other available drug for the same use. "The Bevacizumab Injection is 40 times cheaper than other available drug (Renibizumab Injection) for same use and equally effective in India. This would put less financial burden on patients and prevent blindness of many," says the directive from DCG(I) quoting the committee. Renibizumab Injection is sold by Novartis in various countries under the brand name Lucentis and Accentrix.
The committee proposed that All India Ophthalmological Society (AIOS) and Vitreo Retinal Society of India (VRSI) will formulate guidelines for safe and effective use of the medicine for ophthalmic purpose based on the written-informed consent as practiced globally for off-label use under appropriate environmental conditions by skilled ophthalmic surgeons based on risk-benefit analysis. These organisations would also further ensure that appropriate training and awareness may be imparted to its members. The AIOS, in tune with the recommendation, has already formulated guidelines and communicated it with its members along with details of the consent format, said D Ramamurthy, president of AIOS earlier.