TIDES IN INDIAN PHARMA

TIDES IN INDIAN PHARMA BY LEVIN THOMAS

1. INDIAN GOVERNMENT MAY EXEMPT WORLD’S FIRST DENGUE VACCINE FROM LARGE-SCALE CLINICAL TRIALS:

According to data compiled by India's National Vector Borne Disease Control Programme, until the end of November 2015;  90,040 cases of dengue were reported from 29 states and six union territories with New Delhi leading the chart. This projected figure could be higher as a number of cases are not reported due to low detection rates. This year, 181 dengue-related deaths were reported as of November. Dengvaxia, the brand name of the world’s first vaccine for dengue;  developed by Sanofi Pasteur, a unit of French pharmaceutical giant Sanofi, is being examined by the Indian drug regulatory agency for exemption from large-scale clinical trials on patients. If cleared, the step may eventually pave the way for its availability via the wide government distribution system and private channels. 


 

Sanofi's two-decade-long chase for a dengue vaccine involved investments of 1.5 billion (about Rs 10,700 crore) and clinical trials on more than 40,000 people. The vaccine’s overall efficacy against any symptomatic dengue disease was 60.8% in children aged 9-16 years who received three doses of the vaccine, according to detailed results of clinical trials published in The New England Journal of Medicine . The vaccine showed 95.5% protection against severe dengue and an 80.3% reduction in the risk of hospitalization. A total of 20,869 children from dengue-endemic countries including Brazil, Colombia, Mexico, Honduras and Puerto Rico participated in the study and were randomized to either receive three injections of the dengue vaccine or a placebo. The results were consistent with those from an efficacy study in Asia after a 25-month active surveillance period. Sanofi Pasteur’s phase III efficacy clinical study programme for its dengue vaccine candidate was conducted in over 31,000 participants across 10 endemic countries in Asia and Latin America. The Asian countries include Indonesia, Malaysia, Philippines, Thailand and Vietnam. Meanwhile the  data from India's clinical trial registry showed that the vaccine has undergone Phase II studies in 189 Indian volunteers aged 18 to 45 years in five sites (New Delhi, Ludhiana, Bengaluru, Pune and Kolkata) and was found to be safe and immunogenic in Indian adults. Jean-Pierre Baylet, country head at Sanofi Pasteur (India, Sri Lanka and Nepal), said the data were consistent with its global dengue vaccine clinical studies (Phase I, II and III) carried out among volunteers in Asia and Latin America, including 31,000 subjects in Phase III.

Sanofi filed for the approval of the vaccine in India last month citing widespread prevalence and the high number of dengue cases seen in India. Recently the Mexico's Federal Commission for the Protection against Sanitary Risks became the first drug regulatory agency globally to allow the tetravalent vaccine for prevention of dengue caused by four virus serotypes. The product is not approved for use in children below the age of nine years.  As India reported a record number of dengue cases during this year, the health ministry is exploring the possibilities to accelerate the marketing authorisation of the dengue vaccine in India.

2. SEPARATE MINISTRY FOR PHARMA INDUSTRY AND IMPLEMENTATION OF KATOCH PANEL RECOMMENDATIONS:

At present, Central Drugs Standard Control Organisation (CDSCO) and Drug Controller General of India (DGCI), which deal in regulatory control over the import of drugs, approval of new drugs and clinical trials, are governed by Health Ministry. Whereas, National pharma pricing authority (NPPA), which sets the price limit on essential medicines, comes under Ministry of Chemicals and Fertilisers. Union Fertilisers Minister Ananth Kumar has announced that there will be a separate ministry for pharma and medical devices sector in the next one year, and assured that the government will soon implement the Katoch panel recommendations in the next 100 days to cut bulk drugs import from China in order to benefit the domestic pharma industry.

The government had set up a committee headed by V M Katoch, Secretary of Health Research to suggest ways to reduce the dependence on bulk drug imports from China. India currently meets about 80% of its demand of bulk drugs from Chinese imports. The recommendation of the committee include like providing land at concessional rates,  providing power, single window clearance for licensing of drugs in the country and setting up National Bulk Drugs Development Authority.

Other recommendations include cluster development model for the pharmaceutical sector with tax free status to cluster developers and cluster participants for 15 years. Immediate investment will be provided by the government for development of clusters in the form of a professionally managed dedicated equity fund for the promotion of manufacture of APIs. All central and state duties, taxes, levies etc in creating the entire cluster infrastructure and individual unit infrastructure should be made nil. For this a unit should ensure more than 50 per cent capacity utilization for NLEM products. The panel also recommended soft loans to the units through interest subvention up to 7.5 per cent, at least on par with interbank lending rates. Capex loan to the manufacturers of APIs for high priority drugs with a moratorium of 10 years for repayment was another suggestion. Income tax rebates for upgradation of the existing R&D facilities of the companies should be doubled to 400 per cent from existing 200 per cent so as to encourage development of new APIs.
Revival of public sector drug units, stronger industry-academia interaction so as to facilitate movement of scientists between industry and academic institutions  and the need for industry interaction with various science departments and agencies of the government like DST, DBT, CSIR, ICMR etc for best procedures of production are the other recommendations by the panel.

3. RECENTLY APPROVED NEW DRUGS IN INDIA:

Sl.No	Drugs	Indications
1	Vitamin D3  (Cholecalciferol) Orally  disintegrating strips 2000 IU  (additional Dosage form)	For the treatment of Vitamin D3 deficiency.
2	Dexamethasone  Intravitreal implant  0.7mg (Additional Indication)	For the treatment of visual impairment due to  Diabetic macular edema (DME) who are  pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
3	Zolpidem Tartarate Orally disintegrating Tablet  5mg/10mg  (Additional dosage form)	For insomnia
4	Arteether injection 150mg/mL	Indicated for the treatment of severe malaria  including cerebral malaria and as a second line in  chloroquine resistant malaria cases only

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