The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of ≥ 18 years of age. The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. The vaccine comprises of two components I & II, which are not interchangeable. After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). M/s DRL will import the vaccine for use in the country.
Tag: Drug
Institute of Nano Science & Technology Mohali has developed oral nanomedicine for Kala-Azar
Patients affected by Kala- Azar, scientifically called Visceral leishmaniasis (VL), one of the most neglected tropical diseases may soon find relief in an oral nanomedicine from India.
Drug Prices: Lowering by Eliminating Kickbacks to Middlemen- US Presidential Executive Order
July 24, 2020-Medicare patients, whose cost sharing is typically based on list prices, pay more than they should for drugs while the middlemen collect large “rebate” checks. These rebates are the functional equivalent of kickbacks, and erode savings that could otherwise go to the Medicare patients taking those drugs. Yet currently, Federal regulations create a safe harbor for such discounts and preclude treating them as kickbacks under the law.
The Drugs (Prices Control) Order 1995
In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government hereby makes the following Order
The Drugs (Control) Act, 1950
An Act to provide for the control of the sale, supply and distribution of drugs-Every dealer or producer when selling any drug for cash shall, if the amount of the purchase is five rupees or more, in all cases, and, if the amount of the purchase is less than five rupees, when so requested by the purchaser, give to the purchaser a cash memorandum containing particulars of the transaction.
Certificate of pharmaceutical product issued by Uttarakhand Drugs Control
This certificate, which is in the format recommended by WHO establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.
The Drugs And Magic Remedies (Objectionable Advertisements) Rules, 1955
In exercise of the powers conferred by section 16 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (21 of 1954), the Central Government hereby makes the following rules
The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith.
Ayurvedic Products approved by Central Drugs Standard Control of India as on 02.03.2020
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs
Global Clinical Trial means
Global Clinical Trial means any clinical trial which is conducted as part of multi-national clinical development of a drug. Clinical Trial means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the…
Drug Regulatory Authority of Pakistan [DRAP]
DRAP was established in 2012 enacted under DRAP ACT, 2012. Important Divisions PE&R Licensing Quality Assurance Medical Devices Biological Drugs Controlled Drugs Pharmacy Services Health & OTC Laws connected with Drugs Act, 1976 DRAP ACT, 2012 Contact: Head Office TF…
PROCEDURE FOR GRANT OF DRUGS MANUFACTURING LICENSE IN PAKISTAN
The Central Licensing Board (CLB) at present comprisies of 14 members including experts from the fields of Manufacturing and Quality Control of Pharmaceuticals, Professors of renowned universities, representatives of Health Departments Government of Punjab, Sindh, Khyber Pakhtun Khwa, Balochistan and a Law expert.
