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.