At present there is no control on A pathology labs. There is need for an accreditation system which is managed by organisations of professional pathologists as is done in developed countries.

• At present the majority of labs in rural area are managed by DMLT or CMLT diploma holders. Many talukas in Maharasthra have no post-graduate doctors in pathology.
• This act was drafted without consulting the IMA, n a t i o n a l organisations of pathologists and microbiologists and consumer organisations.
• The act proposes to hand over the control of all pathology labs to the FDA. This is likely to cause grave long-term harm to the health care delivery system. The FDA has only pharmacy graduates and pharmacologists. Its reputation is in shambles, it has failed to even control the drug situation. The Drugs and Cosmetics Act contains many outmoded provisions. Handing over the control of labs to the FDA will open new avenues for corruption.
• The definition of a Controlling Authority only mentions that the controlling authority will be a graduate in pharmacy, pharmacology or medicine, totally irrelevant subjects as far as labs are concerned. The qualifications of inspectors are not mentioned.
• The labs are classified in three groups, and exclude the labs run by DMLTKMLT professionals. This means that these labs will have to be closed down, severely affecting the healthcare delivery in most of the state. The act has many impractical provisions. For example the space requirement of a minimum 500 sq.feet for each lab amounts to closing all private pathology labs. The provisions for licence fees, employment of other staff will cause an extra expenditure of upto Rs. one lakh per year per lab to be borne by the patient.
• The act gives powers to inspectors to inspect labs and take samples. The work in most of the modern pathology labs is by sophisticated equipment and ready-to-use kits. This requires special knowledge and expertise to take samples. Many bureaucratic provisions which will hinder the smooth working of the labs are in the act. Creating an ‘Inspector Raj’ as with chemists shops and making corruption rampant. The consultative committee has only bureaucrats and government hospital doctors. There is no provision for representation from private doctors or consumer organisations.
• This act was drafted not because the government was keen to provide quality services but due to the Bombay High Court’s direction in a case where unrecognised teaching institute was giving DMLT diplomas without permission.
• The ideal solution will be to have an accreditation system run by the national organisation of pathologists. It is also necessary to include DMLT/CMLT labs in this accreditation system.
• DMLT is a vocational course recognised by the Central Government. The State Government cannot make laws which effectively neutralise the welfare schemes of the Central Government.
• A few years ago, the Maharashtra Government had issued a GR allowing DMLT/CMLT/MSc./Ph.D to run clinical and pathological labs independently.
• The national accreditation system for labs, proposed by the national organisation of biochemists some time back, should be enlarged and adopted with suitable modifications for all labs.