The state government hospitals, primary healthcare centres (PHCs) and clinics have taken strong objection to the Union Government's recent reversal of a March 2004 order, which had set tough norms for small-scale pharma units for supplying drugs supply drugs, chemicals, surgicals and miscellaneous items to the healthcare establishments.

The new order, issued just a couple of weeks after the original one, lowers the basic manufacturing standards required for pharma units and requires suppliers to have only a Schedule M certification instead of the earlier stringent WHO-GMP compliance.

Based on the Union Government's order, the Karnataka Drug Logistics and Warehousing Society's (KDLWS) issued a notification to small-scale pharma units, stipulating that primary manufacturers should have a WHO GMP certification with Rs. 1 crore turnover and three years of marketing experience in the related area. The Government of India order further added if units were not under the category of small scale, then the annual turnover required was Rs 5 crore.

Following the March 2004 order, small and medium scale units, whose survival depended on the government supplies, had chalked out strategies to upgrade their production plants to become WHO GMP compliant and strengthen their marketing arms to increase sales turnover to avoid losing government orders.

But two weeks ago, the units received revised order from the KDLWS stating that the GOI had withdrawn its earlier announcement. The new order maintained that small-scale units do not need the WHO GMP certification but instead, required only revised GMP certification and a turnover of Rs 50 lakh instead of Rs 1 crore. The norms for medium-sized units stipulated an annual sales turnover of Rs 2 crore instead of the earlier Rs 5 crore.

The State's healthcare sector views the order could bring down the quality of drugs and other related products to be supplied to the hospitals and PHCs.

While the industry is relieved that there is no need for investing in WHO GMP facility, the state healthcare sector is taken aback at the Government of India order.
"Drugs, surgicals and chemicals supplied to the healthcare institutions will be of poor quality. It will affect patients who cannot afford treatment from private hospitals," they informed.

A section of representatives from the Karnataka Government healthcare sector on condition of anonymity, stated that the quality of drugs in the past was suspect. There were a lot of instances of drugs and consumables being sub-standard, which were eventually rejected. Officials said the products were manufactured by small-scale sector with poor infrastructure.

In Karnataka, apart from KAPL - a public sector undertaking, which is WHO GMP compliant, and a major supplier to the government health institutions, there are around 45 small pharma units supplying to the government hospitals.