Indian manufacturers hope increased production of hydroxychloroquine and paracetamol, along with emergence of reliable COVID-19 therapies, will lead to export restrictions on these two medicines being removed soon. Meanwhile, they are fulfilling orders routed through the government.
India is living up to its sobriquet “pharmacy of the world” as it fulfills a flood of orders for paracetamol, an analgesic and antipyretic, and hydroxycholoroquine, an antimalarial drug being touted as a treatment for COVID-19.
Over 30 countries have placed orders for hydroxychloroquine and paracetamol with the Indian government as the global number of COVID-19...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.
Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
