India has as many as 10,500 drug manufacturing units but just a few hundred inspectors to verify if these units follow the mandatory Good Manufacturing Practices (GMP).

Compare this with the US where the pharmaceutical industry is more consolidated and the number of units far less, but at least three-four thousand inspectors deal with multiple aspects of drug safety, including GMP compliance and labelling requirements.

India’ has some 200 pharmaceutical units approved by the USFDA and in addition to the Indian drug authorities, the FDA is keeping a direct watch on them, as the drugs from these plants can be exported to the US. Thirteen US FDA inspectors are posted in India to periodically conduct inspections at these facilities, in consultation with private auditors.

Industry experts say there can be no comparison between Indian GMP enforcement standards and those in developed countries like US, UK and Europe. A main difference is that while Indian drug regulators practically confine themselves to the quality standards of drugs already in the market, US systems ensure detection of adulteration at various stages of production to ensure the highest quality is maintained before a drug reaches a patient. This is even as adherence to GMP standards is mandatory.

?While Indian drug inspectors check the quality of the finished drug to see if it meets safety and efficacy standards, the US laws are more stringent and go into the entire process of manufacturing and documentation to prevent even the entry of substandard or adulterated drugs into the retail market,? said CM Gulati, a regulatory expert and editor of medical journal MIMS.

The US also uses surprise inspections which include a review of a company?s systems, processes, and records to ensure compliance. FDA inspectors also interview employees to verify whether a company?s records are factual. ?Our inspections are perfunctory. There is hardly any element of surprise,? added Gulati.

Experts said while Indian rules state that 40,000 drug samples have to be tested in a year for adulteration, the reality would be different. Every six months, a drug inspector also needs to visit a retailer or chemist. ?In Delhi alone, there are around 7,000 chemist shops, making it an insurmountable job for the few inspectors we have,? added Gulati.

Dinesh Thakur, the whistleblower in the Ranbaxy adulterated drug case, said it is difficult for the US regulator, despite its stringent regulations, to monitor the quality of drugs manufactured overseas due to significant geographic and cultural barriers. ?Regulatory inspections outside the US present jurisdictional and temporal challenges. A manufacturer located abroad receives advance notification to access the facility and often assists in procuring visas for international travel. In many cases, inspectors seek assistance from the manufacturer to help with a foreign language, different culture, and transportation to remote areas. These challenges remove the element of surprise which the FDA uses to its advantage within the US,? writes Thakur on his blog dineshthakur.com.

To overcome these obstacles, Thakur said ?FDA now has offices in China and India, the two countries that account for a majority of the manufacturing facilities that make generic drugs for the US market?.

However, a big positive emerging from the Ranbaxy episode, where the company has been asked to pay a penalty of $500 million for falsification of data and violation of prescribed manufacturing norms, is that many homegrown firms are turning ?proactively conscious? about the quality and safety standards of the drugs manufactured from India. ?Indian companies are now themselves undertaking detailed inspection of finished products and going for voluntary recall of drugs in case of any irregularity,” said DG Shah, secretary general of the Indian Pharmaceutical Alliance.