Though the Karnataka Drugs Control department will have to take action against units that have not complied with the revised Schedule M norms for quality manufacturing within the stipulated deadline of December 31, 2003, the severe shortage of inspectors in the department would result in more non-complied units evading the standardization norms. Otherwise, it would mean the existing staff overburdened in trying to enforce the GMP.
Currently, there are only three inspectors overseeing 130 drug-manufacturing units. According to the recommendations of the Task Force set-up by the government of India to assess employee strength in government departments, there should be at least one drugs inspector in charge of 25 drug manufacturing units in Karnataka. However, there is a need for seven more drug inspectors.
According to Dr. Suresh Kunhi Muhammed, drugs controller, government of Karnataka, despite staff shortage, every effort will be made to ensure units go in for GMP compliance. If they fail to do so, we will still have to cancel manufacturing licenses, as compliance to GMP is a government order and any violation is an offence.
The revised Schedule M released in December 2001 is more exhaustive than its earlier version of 1988 and the norms recommended are on par with the WHO (World Health Organization) standards.
Out of the 130 allopathic drug-manufacturing units (70 formulations, and 60 bulk drugs), 70 are with GMP certification as per WHO standards. However, the remaining units are almost completely in the small and tiny sector. At the same time in the ISM sector, out of the 251 units, only 7 are GM complied. Around 5-10 percent those who are not yet applied for GMP certification are mainly bulk drug units, which might not be able to go in for this standardization because of financial crunch and small size of operations. Although a large percentage of the 130 units comply with GMP, there are certain deficiencies like lack of air handling systems, ancillary areas, refreshment zones, updated documentation and validation procedures, which Schedule M insists.
The drugs control department is expected to send a circular to these units and create awareness on the criticality of compliance. After the circular, if the units approach the drugs control department, efforts will be made to organize a workshop on GMP compliance. Early this year, a government of India and WHO-sponsored GMP workshop was organized in Tamil Nadu for small-scale units and 40 companies from Karnataka participated.
Companies apply for GMP product-wise or for exports. It may also be for participating in tenders floated by other state governments. GMP certification is issued after a joint inspection of a unit is carried out jointly by the drugs control department, government of India and the State drugs control department. A GMP certification is valid for two years.
The State drugs control department is hopeful that units will take the deadline seriously because it is a challenge for both the department and the units to ensure compliance before end of 2003.