In my Editors Note in last year’s Independence Day special issue, I had asked: as we mark our 71st Independence Day this August 15, how far have we progressed on the medicines security front?
(http://www.expressbpd.com/pharma/editors-note/india-pharma-incs-tryst-with-destiny-continues/388906/) Unfortunately, a year later, the reply is not very encouraging. As part of our Independence Day special coverage this year, we asked experts to explore strategies to improve our performance across three markers: indigenisation, information and innovation to accelerate Indian Pharma Inc’s growth trajectory.
While the Chinese government continues for the sixth year running to close down pharma companies which have been polluting the environment, prices of key starting materials and active pharmaceutical ingredients (APIs) sourced from China have become more expensive. More recently, the Chinese premier Li Keqiang has ordered a detailed investigation into how a Chinese vaccine maker, Changchun Changsheng Bio-technology, had got away with shoddy manufacturing practices and had sold some 252,600 substandard DPT vaccines to the Disease Prevention and Control Centre of Shandong Province. While no child who had been administered the vaccine suffered any adverse effects, the government was provoked into taking action after social media and even government-controlled newspapers criticised it for ‘lax supervision and light punishment’ meted out to the country’s pharma sector.
These are echoes of the situation here in India as well though the CDSCO and regional teams have stepped up raids on companies making drugs without the Drug Controller General (India) (DGCI’s) permission, especially irrational fixed dose combinations (FDCs).
The net once again seems to be closing around FDCs. One of the topics on the agenda for the 80th meeting of the Drugs Technical Advisory Board (DTAB) sub-committee due on July 25, is the decision on 349 (344+5) FDCs. The DTAB sub committee has recommended that 343 FDCs be prohibited and six others be either restricted or regulated for specific indications or quantities. After discussions during the meeting, this report is likely to be sent to the health ministry in the next two weeks, following which the government will decide the fate of these FDCs.
While industry will once again raise protests as they did in the past, this time they cannot say that they did not get a fair chance to present their case. The sub committee’s decision comes after as many as 41 meetings with co-opted experts. All India Drugs Action Network (AIDAN) made 812 representations for 184 FDCs, while 467 companies had hearings for 156 FDCs.
The sub-committee had reportedly found that “most” of the companies appealing the ban had not generated safety and efficacy data of their own for their FDCs. Almost 95 per cent of these appellants is said to have failed to prove safety, rationality and compatibility of these FDCs. The sub committee said that the published literature provided to justify the FDCs was “not relevant” (no epidemiological data from India, meaning the data was not of patients in India) and relied on a few “biased” studies. Indications mentioned were “too broad/absurd/vague” and were not as per treatment guidelines. The sub committee found that for most FDCs, their use would lead to “unnecessary overuse and the patients would be exposed to the risk of multiple ingredients when one would suffice.”
The sub committee has specifically countered the claim to safety by referencing OTC products in other established markets like the UK or US, by pointing out that such appellants ignore the lacunae in the OTC system, label requirements of OTC products (e.g. not for children under 12 years of age), lack of efficacy and withdrawal by innovator of some products. For appellants who wished to change indication and/ or carry out studies in support of their respective FDCs, the sub committee advised them to follow D&C Act for new drugs.
But can one country’s regulations be truly independent of global regulations? India’s track and trace norms continue to have key differences from global norms. This has already negatively impacted pharma exports from India. India’s pharma exporters grapple with differing definitions of packaging levels and data security concerns. The Directorate General of Foreign Trade (DGFT) has announced yet another extension to comply with requirements, but the industry argues that it needs to review its system to be more in sync with global norms. Thus, finally in our 72nd year of Independence, will our pharma regulatory mechanism prove to be independent enough to stand its ground? At least on the FDC issue, for starters? We hope to have the answer in our next issue, which will be the second in our Independence Day series.