SWIFT COMPLIANCE WITH INDIA'S MANUFACTURING RULES URGED

A former senior executive at a major multinational drugmaker in India has urged the local industry not to hesitate in complying with new manufacturing rules. India's government has been considering a further deadline extension for compliance with the so-called "Schedule M" norms, and smaller manufacturers are lobbying to have the new rules diluted.

Small-scale manufacturers in India have been hard hit by the advent of new tax structures based on the pharmaceutical Maximum Retail Price (MRP). Many of the larger players - mainly contract manufacturers for major foreign firms - have already relocated to low-tariff zones in remoter states such as Himachal Pradesh.

The fate of the smaller manufacturers under the new regime appears bleak, but many have managed to remain operational due to official corruption. With the loss of revenue implied by MRP, many now lack the resources to implement new rules obliging minimum standards for features such as air-handling systems. Poor record keeping has also been blamed for non-compliance.

In the meantime, consolidation in the manufacturing sector looks inevitable, and better regulation will be key to ensuring international confidence in India's pharmaceuticals industry. Experts urge other drug manufacturing zones to follow the example of Karnataka state, where officials carry out random quality checks and raids on a more frequent basis.