The document changed the focus of the meeting and turned it towards the average citizen

1. MONITORING OF THE PERFORMANCE OF STATE REGULATORY AUTHORITIES FOR IMPLEMENTATION OF THE STATUTE
The Drugs and Cosmetics Act 1940 is a central legislation, which regulates the import, manufacture, distribution and sale of drugs and cosmetics in the country.

The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and conform to prescribed quality standards and the cosmetics marketed are safe for use.

It has been observed that many of the provisions of the Act which have very serious ramification on health status of the country, have not been implemented effectively by the State FDAs. There is no assessment of adverse impact of non implementation of these statutory provisions on human health. This is a very serious situation. The Food and Drugs Administration, Maharashtra State during last two years, has taken up implementation of statutory provisions that are patient-centric. Had these provisions been effectively implemented during last six decades, the adverse drug reaction/adverse drug events and the resultant morbidity and mortality would certainly have come down.

In Maharashtra State we have started effective implementation of these provision and also initiated monthly monitoring of implementation from the State Head Quarters. It is strongly suggested that, Drug Consultative Committee should evolve mechanism for implementation of all the provisions of Drugs and Cosmetics Act in toto and its effective monitoring at national level.

2. COMMUNITY PHARMACY
According to the Fact Sheet 330 of WHO, about 50% pharmaceutical products are either wrongly prescribed, over prescribed, under prescribed or wrongly dispensed and of about 30 to 40% of drugs prescribed in the third world countries, the patients fail to complete the doses as prescribed.

As per CDC, USFDA, Chief Health Officer of UK etc. the mortality and morbidity and drug resistant phenomenon have assumed extreme serious proportions.

This challenge can be addressed to a certain extent by securing presence of pharmacist in the retail outlets as mandated in the statute. However, we, as a country, have still not secured presence of pharmacists or sale of prescription drugs under the supervision of pharmacists in retail outlets. Dispensing prescription drugs without prescription, dispensing medicine prescribed by a wrong medical professional, dispensing wrong combination of medicines etc, are rampant. In a quick study conducted in Mumbai, it was found that about 34% of outlets were functioning without presence of pharmacists.

We in Maharashtra have started strict implementation of this provision. However, the trade has completely disregarded this provision. That led to announcement of strike on four occasions in Maharashtra State, which were dealt with stern action. The situation in other states would be similar to that in Maharashtra State. In order to promote scientific dispensing of medicine for better health status in the country, we need to secure presence of pharmacist across the country and same should be monitored at the national level.

3. SALE OF MEDICINES WITH BILL
The need for sale of medicine on cash/credit memo is undisputed and the statutory requirement. This has been provided in statute to minimize opportunity of entry of counterfeit medicine and also recall medicine from the patients. However, this provision is being implemented more in breach than in practice. This provision also needs to be implemented and monitored at the national level.

4. SALE OF PRESCRIPTION DRUG ONLY ON PRESCRIPTION
There is unhealthy practice of honouring self medication even for the prescription drugs and this practice is in vogue for many decades in the country. This will lead to adverse impact on the health status of the patients and the generations to come. The sale of the prescription drugs only on prescription should be implemented and should be monitored at the national level.

5. DRUG RECALL
The provision for recall of drugs that has been found to be Not of Standard Quality etc., exists in statue. However, this provision has not been implemented to secure effective recall of such drug, due to delay in analysis and declaration of results of these drugs. This is yet another provision that has remained on paper to a very large extent. The drug recall need to be effectively implemented by the States and monitored at national level.

6. CURB ON MONOPOLISTIC AND RESTRICTIVE PRACTICES IN THE SALE OF DRUGS
Drug is an essential commodity under the Essential Commodities Act 1955. Hence it is necessary in the interest of general public that there should be no restrictive procedure/barrier in the production, supply, distribution and trade of drugs. This statutory provision has to be strictly followed in dealing with drugs. However for the last 30 to 40 years, the Chemist & Druggist Traders Associations were involved in illegal and unconstitutional practices, thereby impeding the supply of drugs and exploiting the consumers.

The Association were involved in high handed pressure tactics and entered in MOU with manufacturers according to which it was binding on the manufacturers to appoint stockist/new stockist or introduce new drugs in the market only after obtaining NOC from the association. The association indulged in malpractices and favoritism in the grant of NOC. FDA has issued circulars with the view of eliminating the monopolistic and restrictive practices of the association. FIRs also being filed against manufacturers and traders who are still indulging in such practices.

Recently, Competition Commission of India has found the association indulging in anti-competitive practices and imposed a penalty of Rs.47 lakh on AIOCD. This action is in consonance with action taken by FDA, Maharashtra. It is expected that the Centre should seriously review this situation and issue directives to all

States to enforce the provisions of Law to curb monopolistic and restrictive practices in the sale of drugs.

7. A UNIFORM INSPECTION METHODOLOGY OF MANUFACTURING UNITS
There is a provision of inspection of every manufacturing unit by the drugs inspector to monitor the condition of licenses as per the provisions laid down in Schedule M, M I, M II, M III., however the varying level of competence of the regulatory official, absence of uniform inspection methodology and training resulted in ineffective and superficial inspections. It is also observed that when international agencies inspect the manufacturing units in India, serious noncompliance and GMP violations are observed.

A uniform inspection methodology for inspections of manufacturing units to secure and protect the quality of the drugs, cosmetics and medical devices manufactured in the country is not existed and followed, to assure the implementation of law for the benefits of patients and the citizens of this country.

8. WHO-GMP CERTIFICATE FACILITATION
This is a common observation that there is a remarkable delay in the joint inspection, scrutiny and processing of WHO-GMP certificates and COPP. This unnecessary delay hampers the export of pharmaceuticals from the country and the country become less competitive.

FDA Maharashtra has taken an initiative in this regard. Applications for grant of certificate, scrutiny and processing are made online. This procedure has reduced the time period required for processing the various certificates essential for export and thereby facilitates the drugs manufacturers and exporters in Maharashtra as compared to other States. This online procedure can play a major role in positively impacting the pharmaceutical export from Maharashtra State. This has curbed chances of corruption.

9. INCLUSION OF MEDICAL DEVICES IN THE LIST OF ESSENTIAL MEDICINE
The major concern of society is the price of various medical devices; many are out of reach of common people because of their unaffordability. However, Central Government has not seriously shown any concern in this regard to include the various costly indigenous and imported medical devices under the purview of DPCO.

It is suggested that all the costly and unaffordable medical devices be included in the list of essential medicine and controlled under DPCO.

10. INCLUSION OF PROVISIONS FOR CORD BLOOD, STEM CELLS BANKING
This administration has received applications for grant of license for processing cord blood and cord blood banking. Also applications for processing of Stem cells from adipose tissue,
amniotic fluid and cord blood are received by the administration.

However at present there are no provisions under the Drugs & Cosmetics Act and Rules thereunder. Only draft notification for Cord Blood banking is published. In view of changing scenario in medicine, there is an urgent need to regulate this area and lay down the provisions for licensing, operating of cord blood banks and Stem cell processing laboratories.

11. LICENCE FOR SALE OF COSMETICS AND AYURVEDIC DRUGS
At present Schedule K Sr. No. 16 provides for exemption for selling license for sale of cosmetics. However there is a possibility of spurious cosmetics being available for sale.

Similarly there is no provision in the Act for selling license for Ayurvedic drugs. To regulate the sale of Ayurvedic drugs it is necessary to create provisions of licensing for sale of cosmetics. This has become imperative on the background of requirement of license/ registration even for any food item under Food Safety and Standards Act.

In 45th DCC Meeting report, DCC opined that in the absence of adequate manpower and logistics, it may not be desirable to initiate sale license for cosmetics in line with drugs. The decision taken by DCC is not suitable on such an important issue.

Disclaimer: The information provided in this feature has been sourced from FDA, Maharashtra.