NEW DELHI: Increasing the heat on Chinese drug firms exporting medicines to India, the Drug Controller General of India (DCGI) is all set to open its first foreign drug inspection office in Beijing by March 1.
Around four Indian drug inspectors will be posted in China to inspect manufacturing sites and check whether good manufacturing practices (GMP) are being complied with.
DCGI Dr G N Singh told TOI that the commerce ministry has cleared the proposal.
Health minister Ghulam Nabi Azad recently said that in the last two years, 10 Chinese bulk drug manufacturing firms were inspected and the registration certificate of one firm and 16 import licences were cancelled.
Ministry sources said the decision to audit Chinese drug manufacturing units was taken after several import licences of local agents were cancelled due to poor drug quality and their failure to comply with GMP.
"We will post Indian drug inspectors in China to send a clear message that Chinese drug firms are under watch. Gradually, China will be asked to only allow drugs exports from manufacturing sites that have been inspected by Indian drug inspectors. We want to ensure safety, efficacy and quality of Chinese drugs," said Dr Singh.
"GMP of Chinese drug firms has to be certified by our regulators. This is a practice followed in most countries, including the FDA in the US. To protect the interest of Indians, we have to go international," he added.
Now, more than 45% of bulk drug exporters registered in India are from China. The number of registered Chinese bulk drug manufacturers in India is around 280, and altogether 417 different drugs from the Asian giant are registered.
In 2009-10, the value of drugs imported from China stood at Rs 3,094.4 crore, while India's total drug import bill was Rs 4,953.87 crore.
The Planning Commission's working group for the 12th five year plan had said in its report that globalization has fundamentally changed the environment for regulating drug products and created unique regulatory challenges for the following reasons: more foreign manufacturing facilities supplying bulk drugs, medical devices, blood products, diagnostics and anti-cancer drugs to India, increasing volume of imported medicinal products and imports coming from countries with less developed regulatory system.
The document said, "It is therefore important that the Central Drugs Standards Control Organization should have India country offices, at least one each in five countries. Initially, such offices could be set up in China and South Africa to inspect foreign manufacturing facilities and address other regulatory issues. The offices in the other three countries could be set up on a need analysis basis. The financial outlay for each office would be Rs 175 crore."
The Indian pharmaceutical industry has been growing at a rate of 11%-12%. It is the third largest in the world by volume and 13th by value. The total size of the Indian pharma industry is about Rs 100,000 crore, out of which exports account for Rs 42,000 crore. It accounts for 8% of global production, and 2% of the world pharma market.
A ministry official said, "We had earlier written to Chinese Food and Drug Authority (FDA) regarding complaints that some Chinese drug firms which export bulk drugs to India might not be holding proper GMP certificates. The Chinese FDA too confirmed our apprehensions and asked us to carry out our own inspections."
On the basis of complaints and doubts on authenticity of GMP certificate, India has already cancelled 10 registration certificates and related import licences. These certificates were from Zhejinag, Jingsu, Henan province and Chongquing.
A DCGI note said, "Similarly, several cases of imported kits of HIV were declared to be not of standard quality by the government laboratory, which are originating from Zhejiang and Fujian provinces. These issues further support this office which stands to carry out foreign site inspections in line with other regulatory agencies of the world."
India to open its first drug inspection office in Beijing by Mar 1
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India to open its first drug inspection office in Beijing by Mar 1
