Even as the drug authorities in the country are gearing up to implement the Good Laboratory Practices (GLP) for the pharmaceutical sector, most of the pharma units, especially the small and medium pharma units, are unaware about the requirements regarding the premises and equipments which should be upgraded as per the Schedule L-1 of the Drugs and Cosmetics Act, 1940.
Though the drug authorities have issued circulars to the pharma units asking them to comply with the GLP, which has become mandatory for the pharmaceutical units in the country from November 1 this year, the drug authorities did not mention any information about the requirements of premises and equipments as per the Schedule L-1 of the Drugs and Cosmetics Act.
Faced with lack of such information, the Madhya Pradesh Pharmaceutical Manufacturers Organization (MPPMO) has asked the state drug controller to provide the information in this regard to the pharma units so that they will be able to follow the norms set by the union health ministry. The MPPMO has asked the drug department to circulate the necessary information in this regard to the pharma units so that they can take steps towards implementation of Schedule L-1.
Besides, the MPPMO has also asked the state drug authorities to prepare a GLP-compliant model drug testing laboratory by the government so that the companies can send their quality control head to the government laboratory to get the proper guidance for upgrading their units as per GLP guidelines.
Earlier, the Drug Controller General of India (DCGI) Dr Surinder Singh had asked the state drug controllers to begin implementation of the GLP from November 1 this year. The DCGI directive in this regard was given to the state drug controllers at the Drugs Consultative Committee (DCC) meeting held on October 28 this year which also discussed several important issues that have been pending for some time.
The government decision to implement the GLP from November 1 has put the industry in real difficulty as a large number of units, especially the small and medium players, have not yet complied the GLP norms due to the huge financial burden involved in it. The GLP standards mandated through the revised Schedule L-1 under the Drugs and Cosmetics Rules, Third Amendment, 2008, demands setting up of costly machines like FTIR (Fourier Transform Infrared Spectroscopy), HPLC, AAS, HSGC, IR machines in every pharma units. Adherence to these norms would require a considerable investment from the small scale units, which are struggling for survival.
In fact, the industry has been under the hope that the government will further extend the deadline fixed by the government two years ago. Several industry associations, including, IDMA SPIC and CIPI, have been urging the government to extend the deadline by at least another two years.