A.P. Pharma Receives FDA Complete Response Letter for APF530

A Complete Response Letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The primary points raised in the FDA Complete Response Letter are discussed below

:Dosing System- The FDA expressed concerns relating to A.P. Pharma's two-syringe administration system, including potential issues with the transfer of material from one syringe to the other syringe prior to patient administration, certain components used in the dosing system and the potential risk of improper administration of the drug product.

Chemistry, Manufacturing and Control- The FDA has completed inspections of A.P. Pharma and several of its contract manufacturing facilities. The Agency identified certain deficiencies during these inspections, and satisfactory resolution of these deficiencies will be required for approval.- During the NDA review, the FDA asked that the Company determine if terminal sterilization with gamma irradiation is a feasible approach to enhance the assurance of sterility. A.P. Pharma has subsequently demonstrated that terminal sterilization is feasible, and the FDA has requested the Company change to terminal sterilization prior to approval.-- The FDA requested clarification and revision of certain analytical specifications proposed in the Company's NDA.....................&more.

US FDA ‘Satisfied’ With Indian Pharma’s Manufacturing Facility

Indian pharma major Lupin says the US FDA is now satisfied with the corrective actions taken at its Mandideep facility in Madhya Pradesh. An official communication has been received from the US agency on the issue.
In May last year, the FDA had warned the company that no new product would be approved until it took corrective action to address the deficiencies in the Mandideep manufacturing plant. It is Lupin’s only plant manufacturing cephalosporins, which contribute about 45% of its total revenue.
The FDA inspection found several deficiencies in the Good Manufacturing Standards (GMP) standards set by the agency and issued Inspectional Observations also known as Form 483 listing all the deviations.
It cited Lupin’s failure to maintain production, control, or distribution records and failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products to be sterile....................&more

Ministry completes national fake drug study

The ministry of health and family welfare‘s nationwide survey on the extent of fake drugs in India is finally complete. The official report will be submitted to the Drug Controller General of India early next week. ―We collected and tested more than 24,000 samples to find out if they are spurious (or fake), counterfeit or sub-standard. Our suggestion to the center will be to have an ongoing study and not just end here,‖ said D. Roy, deputy drug controller, north zone, who led the survey. According to trade journal ‗Pharmabiz‘, of the 24,000 samples, only around 10 were found to be spurious. This is on a par with another study conducted by SEARPharm, which had put spurious drugs at 0.3% of the 10,000 samples it collected. Based on a model prepared by the Indian Statistical Institute, Hyderabad, the survey spread over a year and collected medicine samples from every state.

who

The World Health Organization
(WHO) has warned over the rising instance of tobacco consumption among youth in India which has in turn led to a spike in cases of oral cancer
According to the stats released by WHO, the percentage of children aged between 13-15 years who smoke has risen to 5.8 percent among males and 2.4 percent in females while the overall consumption of tobacco among children is around 16.2 percent.
Prasad Oak who is the counselor at the Anandvan Bahuddeshiya Sanstha said that children often start consuming tobacco by watching their parents. “The children mostly inherit the habit from their parents. Among slum dwellers, consumption of tobacco by children is not usually considered a bad habit as the adults themselves are unaware of concomitant effects of tobacco”, he said.................&more.