Some months ago, Indian regulators posted a notice that a couple of batches of an Abbott ($ABT) cough syrup was defective, that it contained twice the level of codeine is allowed by law. But the episode, which has been going on for about 9 months, is turning out to be less about flaws in the drugmaker's manufacturing practices than about the flaws in India's system of oversight.
Reuters in an exclusive story reported that a state lab in West Bengal posted the notice last February after Indian regulators confiscated some bottles of what they said were Abbott's Phensedyl, a popular product that accounts for a third of the cough syrup market. When Abbott tested its batch samples, however, it were found to be in compliance. Months after asking India to provide one of the samples so it could determine if it was a counterfeit, it has yet to get one. Two different authorities each insist it must be obtained from the other.
"We are awaiting response from the authorities," the company told Reuters in a statement.
India currently has about 1,500 inspectors to oversee an estimated 10,000 drug manufacturing facilities. Under pressure from the West, it has pledged to spend about $263 million in the next three years to hire and train inspectors and to add to its laboratories. But in the meantime, it has taken few if any steps against any its large domestic drugmakers that the FDA has often found fault with, while companies like Abbott find themselves defending their reputations over issues that they may not even be responsible for.
The cough syrup products in the Abbott case were taken near the border of Bangladesh, according to a state inspector. Reuters reports that because products containing codeine are banned in Bangladesh, they are often counterfeited and smuggled into that country.
Navneet Marwaha, the drug controller in the Himachal Pradesh, acknowledged that counterfeiters often target the cough syrup market, and that Abbott has been able to account for all of its product. "They (Abbott) are saying 'show us the sample so we can see whether it is genuine.' They have not been provided with the sample," Marwaha said.
Marwaha said it was up to West Bengal authorities to provide the information to Abbott but authorities there say they have neither the time nor the resources to follow up and that the they can't hand over the sample without approval from Himachal Pradesh. They also said the drugmaker would need a court order to get it. In the meantime, Abbott has left the product in the market.
Shortcomings in India's regulatory system became front and center several years ago when former FDA Commissioner Margaret Hamburg during a visit to the country urged government and industry leaders to do more to upgrade manufacturing quality and oversight. Indian regulators have taken few, if any, steps against Indian drugmakers with which the FDA has had repeated problems. The agency has banned products coming out of plants of Ranbaxy Laboratories, Sun Pharma, Wockhardt and others after finding they had faked data to indicate that batches that failed certain test standards were good enough to be shipped to the U.S. Indian authorities in the past have said they looked over these facilities but never found anything that warranted stopping production. They claimed Ranbaxy's finished products met Indian requirements.
Under mounting pressure, including from lost exports, the government is taking steps to do better. The Central Drug Standard Control Organization (CDSCO) is doubling its inspector headcount to 1,000 and has been sending trainees on plant visits with international inspectors, including from the FDA, so that they can learn to evaluate the facilities as the Western inspectors do.
- read the Reuters story