A large number of applications are being filed to the office of DCG (I) at CDSCO (HQ) by Pharmaceutical companies, both manufacturers and CRO’s on behalf of them, requesting for the approval to carry out Bioequivalence studies on Indian subjects for export purpose.
The government is encouraging enrichment of food items with micronutrients to remove dietary deficiencies among its citizens, Minister of State for Health and Family Welfare Ashwini Kumar Choubey said.
In order to promote fortification as a means to address micro nutrient deficiencies, the Food Safety and Standards Authority of India (FSSAI) has operationalised the draft Food Safety and Standards (Fortification of Foods) Regulations, 2016 in October 2016, he said in a written reply to the Rajya Sabha.
Choubey said FSSAI has established Food Fortification Resource Centre in collaboration with Tata Trusts and various international NGOs working in the field of nutrition as a resource centre to promote large-scale fortification of food and to nudge and facilitate food businesses to adopt fortification as a norm.
At present, all the major oil producers in the country are voluntarily fortifying at least one brand in their product portfolios, he said.
The regulations include provisions regarding standards for fortification of food articles namely wheat flour, rice, milk, edible oil and salt with vitamins and minerals, said the minister to a query on the laws for food fortification in the country.
The FSSAI may from time to time mandate fortification of any food article under the regulations on the directions of the Central or the state governments in consultation with stakeholders, he added.
The Women and Child Development Ministry and the Human Resource Development Ministry have advised the use of double fortified salt with iron and iodine, wheat flour with iron, folic acid and vitamin B-12, and edible oil with vitamin A and D under their Integrated Child Development Scheme and Mid-day Meal Scheme.
Under Food Safety and Standards (Prohibition and Restriction on Sales) Regulations, 2011, sale of only iodized salt is permitted for direct human consumption.
Further, Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 provide that vanaspati should contain synthetic Vitamin A.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation.
Foods for special medical purpose (FSMPs) is a category of foods that has been harmonised with the IMS Act to save the lives of babies suffering from inborn errors of metabolism (IEM), a life-threatening medical condition affecting thousands of infants in the country.
The National Pharmaceutical Pricing Authority fixes/revises the price of the Scheduled formulation.
The scheduled formulations are: Atorvastatin + Aspirin Capsule (Atchol-ASP 150), Nifedipine + Lidocaine Cream (LOXHEAL), Pioglitazone + Gliclazide + Metformin Tablet (GLZ Total), Ibuprofen + Paracetamol Tablet (Brufen Plus), Misoprostol Tablet, Glimepiride + Metformin Tablet, Melphalan + Povidone Injection (Melphalan Injection IP 50mg), Trastuzumab Injection, Vitamin D3
(Cholecalciferol) (DRISE SURE), Furosemide Injection, Snake Venom Antiserum-Soluble/ Liquid Polyvalent Injection, and Phenobarbitone oral liquid.
As per notification dated 23 February 2018, NPPA has fixed retail prices of 14 formulations under Drugs Prices Control Order, 2013.
[adsense:336x280:8701650588]
After KMC’s crackdown on unsafe packaged water, the state has made it mandatory for all such water units to have certification from two food-security authorities, besides the Bureau of Indian Standard (BIS) seal of approval.
Shri J P Nadda, Union Minister of Health and Family Welfare launched the ‘‘Viral Load testing for all People Living with HIV/AIDS (PLHIV),”at a function.
The initiative will provide free of cost viral load testing for 12 lakh PLHIV on treatment in the country at least once a year. Shri Nadda further announced that after ‘Treat All’, Viral Load test is a big step forward in treating and monitoring people living with HIV. “This Viral Load test is of immense importance to monitor the effectiveness of treatment of patients taking lifelong Antiretroviral Therapy,” he said.Smt. Anupriya Patel, Minister of State for Health & Family Welfare was also present at the launch function.
A new clinical study led by the National Eye Institute (NEI), part of the National Institutes of Health, will follow 500 people over five years to learn more about the natural history of early Age related macular degeneration (AMD).
With an aim to boost the medical equipment and devices sector, the State government has signed 25 MoUs. At the summit, a total of 25 MoUs worth Rs 5,090 crore with an employment opportunity of 4,750 jobs pertaining to the health sector were signed.
CLICK HERE TO SUBSCRIBE,
PHARMATUTOR's DAILY EMAILS
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
