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Posted 11 October 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of drugs to renew their licenses periodically.
Singh has given the industry until 21 October to comment on the proposals, although the regulator is yet to fully flesh them out. DCGI has provided the most detail about the license renewal plan. If implemented, companies would no longer need to apply to have various licenses renewed. Instead, Indian regulators will visit their operations, at least every 10 years, to check they still comply with the relevant regulations.
The second proposal could affect some of those regulations. Singh is proposing to carry out a gap analysis to bring Indian GMPs on a par with those set and enforced by WHO. Gap analyses are a way for organizations to assess what steps they need to take to get from their current state to their desired future situation, in this case parity with WHO GMPs. DCGI is yet to provide more details on the process or its timelines.
Taken together, the two proposals address some of the most pressing priorities for Singh and his colleagues. The plan to put Indian GMPs on a par with WHO guidelines forms part of a long-standing push to improve the quality of drugs manufactured and sold in India. This campaign has been buttressed in recent years by actions the US Food and Drug Administration has taken against Indian manufacturers, and the fallout from the linking of adulterated medicines to the deaths of 15 women at a sterilization camp in 2014.
The other proposal fits in with recent initiatives to make the Indian regulatory environment more amenable to business. If the DCGI goes ahead with plans to scrap the license renewal process, the idea will join changes to clinical trial filings on the list of recent, business-friendly regulatory revisions. The notice to unveil the proposals also cites the adoption of a risk-based approach to inspections of drug production plans and staff training programs as ways in which the Central Drugs Standard Control Organization (CDSCO) has streamlined its activities.
The DCGI has set a deadline for the adoption of the Sugam portal for global clinical trial applications, with Singh demanding companies use Sugam for their filings from 24 October onward, while also asking applicants to continue submitting hard copies until told otherwise.
Indian officials first proposed to add clinical trial filings to the list of submissions made through the online portal in August. Since then, complaints by contract research organizations (CROs) have forced CDSCO to convene a meeting to discuss the ways in which the online portal was failing to meet their needs. Those complaints related to uploading documents when seeking clearances for bioavailability and bioequivalence studies, but they form part of a body of evidence that suggest Sugam is still not running completely smoothly.
In his letter to communicate the deadline for adopting Sugam, Singh said the portal’s “robustness was tested by the industry users in several iterations.” Despite this display of confidence in Sugam, Singh is not completely abandoning paper for clinical trial applications. From 24 October and until further notice, applicants will have to send submissions through Sugam and as hard copies. Making companies continue to submit hard copies should mean CDSCO is alerted quickly to any missing information or other problems with online filings.
At this stage it is unclear how long DCGI will make companies submit their applications twice. The next step is for organizations involved in global clinical trials to register on the portal.
The Health Sciences Authority (HSA) of Singapore has approved Sanofi’s dengue vaccine, Dengvaxia. HSA made the decision after analyzing data from two major clinical trials and 22 supportive studies, which led it to conclude the vaccine can prevent infection by four serotypes of the dengue virus.
Sanofi has received clearance to use the vaccine to prevent infection by the 1, 2, 3 and 4 serotypes of the virus in people aged 12 to 45 years old. HSA made the recommendation despite Dengvaxia faring comparatively poorly against the DENV-1 and DENV-2 strains that are most prevalent in Singapore. The vaccine was, at best, 50% effective in these strains. In contrast, effectiveness in DENV-3 and DENV-4 topped 75%.
HSA took a harder line on the age restrictions of its approval. Sanofi tested the vaccine in people aged nine years old and up and other countries, such as Mexico, have approved it for use in children that young. HSA, however, is concerned about data from the Asian trial that link Dengvaxia to a 30% increase in the risk of hospitalization in children aged nine to 11 years old. In response, HSA has set 12 years of age as the lower limit for use, but may revise its position once Sanofi has follow-up data.
Even with this label restriction, the approval is a boost for Dengvaxia, the rollout of which has been slower than expected. Sanofi had hoped to have the vaccine licensed in 20 countries with a total population of 1 billion by the end of last year. However, it took until June 2016 for Sanofi to rack up five approvals. Since then, the pace of approvals has accelerated as Sanofi has stepped up its activity in Asia. With Singapore, Thailand and Indonesia all backing the vaccine, Sanofi now has 11 approvals.
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The DCGI is pressuring Fleming Laboratories to focus its resources on increasing output of the active pharmaceutical ingredient (API) penicillamine. Singh wants Fleming to ramp up production of the API quickly to offset the effects of disruption in the supply of the ingredient from China.
Fleming was one of a handful of companies Singh called to a meeting late last month to discuss why the chelating agent penicillamine, which is on the World Health Organization’s Model List of Essential Medicines, was in short supply in India. Panacea Biotec and Chandra Bhagat Pharma both linked the problem back to the cessation of API supplies from China. Chandra Bhagat attributed the disruption to the renovation of the Chinese API supplier’s facilities.
With supplies from overseas cut off, Singh is pressuring local API manufacturers to step up. Fleming said it can produce 200 kg of the API a month, but at the time of the meeting was operating below that level. The company had just supplied 23 kg of API to Panacea Biotec and was aiming to have a further 45 kg ready within three weeks. DCGI Singh told Fleming to divert resources from other areas to get to full capacity as soon as possible.
The situation is an example of the supply risks Indian companies have created by relying more and more on Chinese manufacturers for APIs. In response, the government that came to power in 2014 made bulk drugs a central component of their “Made in India” campaign. The initial plan was to establish a bulk drug manufacturing policy intended to make India self-sufficient in APIs by 2020. However, the policy was dropped earlier this year in favor of the creation of bulk drug parks.
Tags: Asia Regulatory Roundup, DCGI, India, GMPs, clinical trial applications in India
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