India’s plan to post a team of officials in China for quality inspection of drug manufacturing units in that country in March is likely to get delayed indefinitely for lack of diplomatic clarity between the two countries, according to two senior government officials familiar with the development.
“There is no indication as yet from the ministry of external affairs in this regard, and it is certain we will miss the March deadline,” said one of the senior officials at the Drugs Controller General of India (DCGI) office on Monday. The second official confirmed this. Both officials did not wish to be named.
On 22 December, several newspapers including Mint reported that DCGI was planning to open its first drug inspection office on 1 March in Beijing.
In December, the health ministry decided to set up a permanent drug manufacturing audit and quality certifying office in China following increasing imports of drug inputs that had the potential to compromise the quality and safety of drug ingredients and intermediates being exported from these units to India.
In December, India’s commerce ministry cleared the proposal, following which DCGI said there will be at least four Indian drug inspectors posted in China to examine manufacturing sites and check that these units are complying with good manufacturing practices.
Drugs controller general of India G.N. Singh told Mint on Friday, “It (the Chinese office) is with the foreign ministry at present, and some progress in this regard at the diplomatic level is awaited.”
The director of the East Asia division of India’s ministry of external affairs, Shambu S. Kumaran, who handles the project, could not be contacted for comment; he wasn’t available in his office. Ninad S. Deshpande, under secretary (China) at the same division and directly in charge of the project, said he is not authorized to speak to the media.
The proposed Beijing office of the Central Drug Standards Control Organization (CDSCO) of India is equivalent to the audit office of US Food and Drug Administration and other representative offices of any foreign drug regulatory agency which operates in India and elsewhere.
On 11 February, Mint reported that imports of drug ingredients and intermediates from China had been growing substantially since 2010, almost doubling in 2012 as compared to the previous year. The rise in imports is mainly due to a local shortage of key ingredients, including penicillin and its derivatives, for a broad spectrum of anti-infection medicines. It is also due to the local pharma industry’s attempts to cut the cost of inputs. A substantial increase in imports of active pharma ingredients from China is a serious concern for the government and the drug regulator in particular because the quality of many such products is generally considered to be inferior and not in compliance with good manufacturing practices.
In 2005, the Indian government made import registration of foreign drug manufacturing units, including Chinese units, mandatory for import of drug materials into the country. But site inspections at these foreign units have not been regular as India did not have the resources to carry out the inspections.
There have been a number of instances in the recent past of customs officials seizing consignments of inferior drugs imported from unauthorized factories in China.
In October, health minister Ghulam Nabi Azad said that in the last two years, the Indian drug regulator had inspected 10 Chinese bulk drug manufacturing firms, and the registration certificate of one firm and about 16 Chinese import licences held by Indian traders were cancelled.
A site inspection and certification of exporting units in source countries is an effective method of ensuring quality. But such inspections are rare in China in the absence of a local set-up, said two senior officials at CDSCO, who did not want to be identified. According to officials at various ports in the country, there have been cases of several drug ingredients entering the country labelled as general chemicals, which are not typically monitored by the drug regulators posted at these ports.
DCGI’s Singh told Mint on Friday that the drug regulator had decided to reinforce its monitoring at all ports by empowering officials to take action and increasing the number of inspectors at key ports.