Date: 03-Feb-2020

Maharashtra registers increase of 11 own WHO-GMP units over past one year to take the total to 249 units till date

Going by the Union health ministry’s mandate towards upgradation of Schedule M units to WHO-GMP standards, the Maharashtra Food and Drug Administration (FDA) has registered an increase of 11 own WHO-GMP drug manufacturing units over the past one year taking the count to 249 from the previous 238 WHO-GMP own licensees. As of today, Maharashtra boasts of a total of 423 WHO-GMP certified drug manufacturing units which also includes 174 loan licensees. Besides the government’s mandate towards global regulatory harmonisation, this is also attributed to WHO GMP certificate generation system introduced by the FDA two years ago which provides WHO GMP certificate to the exporters in 10 days time. Besides creating an electronic storage of data for easy retrieval at any time, the new online system developed by the FDA ensures avoiding duplication or counterfeiting of the certificates by assigning a software generated unique authorisation code to each certificate. Among the other unique attributes of the system, the SMS delivery system keeps the manufacturers updated when they are offline and authentication of the certificates can be verified by the authorities very easily. The manual process was time consuming and entailed scrutiny of the application at three levels by the concerned authorities which once approved was sent by post as a Compliance Letter. This system was followed from 2,000 to August 14, 2012. Earlier, joint commissioner (HQ) was designated for signing the various certificates issued under the WHO GMP certificates. Manufacturers from across the state had to come to Mumbai to apply for the certificates and had to submit a sizeable amount of data in the form of papers. The application thus received was cumbersome as it was first received by the drug inspectors at WHO-GMP section and then by the assistant commissioner, WHO-GMP section followed by the final signatures on the certificates by the joint commissioner (HQ). The current upgradation to WHO-GMP level is being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices. GMPs is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel. Central Drug Standards Control Organisation (CDSCO) successfully concluded training sessions for drug inspectors in the past three years on risk-based inspection and good manufacturing practices (GMP) to help equip drug control officers with the latest GMP modalities.