Generic drugs to carry quality mark

In a move to regulate quality in the Rs 35,000-crore generic drug market, the government now proposes to introduce quality mark for these drugs. The move will help consumers distinguish between quality and substandard medicines.

According to sources in the Ministry of Health and Family Welfare, the proposal has been mooted in order to check the growing incidence of spurious generic drugs being detected in the market. “Since generic drugs are not patented, these can be manufactured without paying royalty. Since food items and almost all other manufactured goods get a quality certification (Agmark or BIS certification), we have proposed that generic drugs, too, should get quality certification as these are life-saving,” said the official, requesting anonymity. He said this was part of the efforts being made by the ministry to monitor the quality of drugs sold in the country.

The idea of introducing quality mark for generic medicines was first proposed by the Pronab Sen Committee. It had said a number of small scale units were manufacturing generic medicines, often ignoring quality. The proposal was also supported by the Planning Commission in its earlier recommendations for the 11th Five-Year Plan.

The move, however, has not been taken too kindly by the 5,000-odd small scale pharma companies. These companies see the move as being pro-big pharma units and as to eliminate competition being provided by them. These firms say since they have little expense at their disposal, they would not be able to implement good manufacturing practices (GMP) or apply for and get certification. If big companies get the quality logo, they will get major chunk of the business and SMEs will have to close shop.

The SME Pharma Industries Confederation has now taken up the matter with the government. In a letter to the Prime Minister, the confederation has said small pharma companies would not be able to afford the certification. “We are already working with thin margins, especially after the mandatory upgradation as per GMP; increase in regulatory expenses; and, being deprived of supplying medicines for government orders on the pretext that the turnover is less that Rs 50 crore. Instead of turning us out of business, the government should upgrade its own vigilance mechanism for checking spurious drugs,” said Jagdeep Singh, president of the Punjab Drug Manufacturers’ Association.

Source: The Tribune

US FDA to start operations in India from August, to have 12 officials by 2010

The regional office of US Food and Drug Administration in India is all set to commence its operations with eight staff in the month of August, 2009. The US drug regulatory body will have a total 12 experts in India by the beginning of next year to inspect and monitor the FDA approved facilities in India and to work with the Indian drug regulator on various issues, it is learnt.

At present, six staff including Bruce Ross, country director, US FDA, one senior technical expert for medicines, two senior technical experts each for foods and medical devices has taken charge in India while two officials will join the office within by next month. Out of this, three drug inspectors would be working in Mumbai whereas two inspectors for medicines division will be joining at New Delhi in next year, informed Bruce Ross.

"There will be five inspectors by 2010 working in India to learn more about the inspections and working methods of Indian medicine companies exporting to US. Our office in India is not going to speed up the process of approvals, but will ensure a link of communication between the Indian pharma companies and the Centre office at US," said Ross.

The imports of medicines from India to US growing at a higher pace and the US FDA is trying to understand the Indian ecosystem and to work with the Indian regulator for better monitoring and control system. At present, 10.6 per cent of the total Indian exports to US comprises of medicines even as the rest of nearly 90 per cent is related to food sector. The imports of medicines from India was US$ 1.38 billion in the year 2007-08, but growing at 39 per cent in dollar terms, which is higher than imports from many other countries. Out of the 6300 active drug master filings (DMFs) with the US FDA, almost 25 per cent equal to around 1700 are from Indian companies, said Ross.

The US FDA is currently guiding the Indian drug regulatory body in various regulatory issues including ensuring of standards of medical devices. However, the Indian office would only act as per the directions of the US FDA centre office and the inspections and approvals will be scheduled and decided in Washington. The feedbacks and complaints on common interest from the Indian companies would be channelled through the Indian office, said the officials in a meeting with the industry here.