The recent sterilization tragedy in Chhattisgarh that left scores of women dead has brought Indian drug industry under Western media's scanner again. Leading publications such as Wall Street Journal and the Financial Times have weighed in on the lack of proper norms to curb India's drugmakers, many of whom have established a global presence for manufacturing cheaper generic drugs.
Quoting Indian drug industry executives, a Financial Times report on Wednesday said that the deaths highlights the urgent need for tougher regulation of India’s domestic pharmaceutical industry.
"In particular, they say, India urgently needs to crack down on thousands of small, fly-by-night drugmakers that typically supply government hospitals, and overhaul its official procurement process to ensure distribution of high-calibre medicine to the poor," FT said.
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“India has a generic drug industry that makes the best quality medicine and exports it to the rest of the world, but then those medicines are not reaching Indian patients,” it quoted an official with an international health organisation as saying.
At one small operation in northern India, industry executives had watched as seven employees, sitting on the floor, filled gelatin capsules with a powder with their bare hands, the report said.
"On paper, India has an elaborate regulatory system. As well as a national drug regulator there are state-level regulators that are supposed to license and monitor drugmakers in their states. But in reality the national regulator is severely understaffed and lacking in modern equipment and resources," the strongly-worded article said.
Criticizing state level drug regulators, the report said that they lack not just the expertise, but are also susceptible to accepting hush money to avoid reporting infractions.
India is the largest supplier of generic drugs -- which are copycat versions of patented ones, typically with only minor differences in process -- to the the US in terms of volume. it also has the largest number of drug manufacturing plants approved by the US Food and Drug Administration (FDA) outside that country. However, Indian companies have been under the scanner of the FDA in last couple of years due to violations of manufacturing norms, the most famous of which has been Ranbaxy Labs. Import alerts (which bans import of drugs into the US) issued against Indian plants in 2013 accounted for 49%, or almost half of the total of 43 such alerts issued by US FDA worldwide.
A WSJ article, headlined "Deaths Put Spotlight on India’s Sterilization ‘Camps’", slammed the Indian government’s family-planning program through surgical sterilization of women.
The article, published last Thursday, says that the medicines in such procedures used are Indian-made brands of ciprofloxacin, a commonly used antibiotic (also known as ciproxin and ciprocin), and ibuprofen, a painkiller, as well as the anesthetic lignocaine.
While the cause of the deaths has not been conclusively determined, a preliminary investigation found traces of rat poison in the antibiotic supplied by Mahawar Pharmaceuticals, a local drugmaker that has earlier faced a ban for making sub-standard medicines. The company has termed the latest allegations ‘baseless’ even as its promoters have been taken into custody.
India’s government, seeking to curb population growth in the country of 1.2 billion, offers cash incentives to women, physicians and health workers participating in such surgeries. Around 4.5 million women were sterilised in the year ended March 31, 2013, the Journal says.
"A visit Thursday to the site of Saturday’s surgeries discovered a hospital with windows missing glass and floors covered with animal feces," it said.
A report by Arab News this Tuesday also criticised the programme, saying Indian officials need to revisit their population control policies and methods.
"The policy of offering incentives to health workers for promoting sterilization needs to be reviewed, as apparently it has changed the overall nature of this program,” it said. “The authorities must ensure that incentives should not make health workers insensitive to the plight of the poor and uneducated masses in the rural areas.”
A blog in the Washington Post on Friday recalled Sanjay Gandhi’s infamous sterilisation programme for men in the Seventies. "A policy that targeted men with coercion and sometimes force during Prime Minister Indira Gandhi’s "emergency rule" from 1975 to 1977 caused a lasting backlash. However, policies that targeted women have endured," the Post noted.
According to recent United Nations data, more than 35% of Indian women who were married or in a relationship have undergone sterilisation. Only Puerto Rico, the Dominican Republic and El Salvador ranked higher than India.