The COVID-19 lockdown for India’s Central Drugs Standard Control Organisation (CDSCO) and its field offices and laboratories will end next week. All staff must either take leave or return to work Monday, according to an office memo sent out Thursday. The CDSCO also this week advised companies on submitting attestation of regulatory documents to support applications for import registration, given the challenges of conducting business during the pandemic. Recognizing the difficulty companies are having in getting notarized, apostilled and embassy-attested documents such as manufacturing licenses and good manufacturing practice (GMP) certificates, the agency said the documents may be self-attested. However, once the situation returns to normal, companies must submit notarized, apostilled copies of the documents.
So far, the FDA said Thursday, it has been able to meet its key user fee performance goals for drug reviews, approve applications and communicate with applicants while responding to the demands caused by COVID-19. But “with many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely,” the agency said. If there’s an increase in drug shortages and supply disruptions, it will have to reprioritize its work, it added.
Given the shortages of several drugs needed to treat patients hospitalized with COVID-19 infections, the FDA issued a guidance Thursday on a temporary policy to allow registered outsourcing facilities to compound some of those drugs during the public health emergency. Under the policy, the FDA said it does not intend to take action against outsourcing facilities for compounding certain drugs that are essentially a copy of an approved drug, using a bulk drug substance that is not on the agency’s 503B bulks list, or not meeting GMP requirements with regard to product stability testing and the establishment of an expiration date when certain circumstances are present. The policy went into effect immediately and will remain in effect for the duration of the public health emergency. The drugs that may be compounded under the policy are subject to change, the FDA said.
Yet another drug is being recalled in the U.S. over concerns of potential N-nitrosodimethylamine (NDMA) contamination. This time it’s three lots of Amneal Pharmaceuticals LLC’s nizatidine oral solution, which is used to treat ulcers. Earlier this month, the FDA asked manufacturers to immediately withdraw all prescription and over-the-counter heartburn drugs containing ranitidine from the U.S. market after it found that the level of NDMA impurities can increase over time and when drugs are stored at higher temperatures. Over the past few years, several blood pressure drugs containing sartans have been recalled across the world due to higher levels of NDMA, which is classified as a probable human carcinogen.