The Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has embarked on a major exercise to move from Schedule M to PICS, making it the first industry association in the country to do so.

The Pharmaceutical Inspection Co-operation Scheme (PICS) which is on the top of the mind for India is a course of action to harmonise inspection procedures globally with the common standards of good manufacturing practices (GMP). At a daylong event KDPMA went on to draw the attention of the pharma industry to deliberate on the topic ‘The Essential Journey from Schedule M to PICS'.

The event was inaugurated by Dr S Eswara Reddy, Drugs Controller General of India who stated that both the regulator and the industry need to team-up to put in place global standards for PICs.

Highlighting the need for PICS was Sunil Attavar, president, KDPMA who said, “The expectations have moved from Quality by Analysis to adopt Quality by Design. There is a need for the industry to upgrade if it has to meet the growing expectations of both the global and also domestic markets . Moving from Schedule M to PICS standards is one step to take us there . Expectations are high and the journey is going to be tough for the industry but we need to be proactive and start the process.”

Small and medium enterprises (SMEs) are the fabric of the industry and therefore we need to offer them full support in the process to upgrade. We cannot leave them behind, he added.

Karnataka’s additional drugs controller Amaresh Tumbagi noted that for being PICS compliant, there is need to strengthen the regulatory standards.

Kicking off the technical session with an introduction to PICS, Dr. Premnath Shenoy, chief technical officer, Dossier Solutions and Service stated that it would facilitate exports and is a cost saving import control mechanism. The process calls for mutual recognition of inspections. It will create uniform inspection systems.

The assessment process is identical to the EU Inspection Report format. It provides training to new inspectors or existing inspectors keen to improve their skills in a specific field. During a routine inspection, teaming up a junior inspector with an experienced inspector is enabled. But unless Schedule M is revised, PICS cannot be implemented, added Dr. Shenoy.

The second session by Mala Mohan, director, site quality, Cipla in Bengaluru highlighted the regulatory expectations for PICS. This was followed by AG Raghu, pharma consultant who focused on the topic ‘Moving to PICS needed a culture change’. There was also a presentation by Kotak Mahindra Bank on the ‘Innovative solutions for the pharmaceutical companies’.

Also present on the occasion were Dr. TV Narayana, president, Indian Pharmaceutical Association and Suresh Khanna, secretary Indian Pharmaceutical Association and managing director, Dossier Solutions.