[india-drug] Re: India's Drug Policy (3)

["DSPRUD" <dsprud2005@yahoo.com>]

India's Drug Policy (3)
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Dear I-Drug Members,
   
  This is in continuation of Dr. Usha Gupta?s message dated 18 June 2006, on the new Drug Policy. 
   
  The Economic Times ? New Delhi of June 19, 2006, carries an item on the objectives of the new drug policy, which is reproduced below: 
   
  Quote
  
  What?re the objectives of new drug policy?
  
  The new drug policy is an all encompassing policy framework that is being drafted by an expert committee to provide guidelines to the pharmaceutical industry. The main objectives of this policy are: 1) To ensure availability of essential pharmaceutical products at reasonable prices; 2) To strengthen the indigenous capability to produce cost effective and quality product and export pharmaceuticals by reducing barriers to trade in the pharmaceutical sector; 3) to strengthen the system of quality control over pharmaceutical production and distribution; 4) To encourage R&D in the pharmaceutical sector and; 5) To create an incentive framework for the pharmaceutical industry which promotes new investment into the industry.
  
  Why is the policy critical to the pharmaceutical industry?
  The pharmaceutical industry has been long expecting reforms in the numerous policies that govern the sector. One of the most crucial areas that the policy seeks to address is that of pharmaceutical pricing. Pricing of drugs has been a bone of contention between the industry and the authorities ever since the price control was instituted.
  
  How has price control on drugs evolved?
  Control over cost of medicines to the consumer exists in one form or the other in most countries. Government?s control over drug pricing in India had begun in the context of the Sino-Indian war, but a structured price control mechanism was first instituted in 1979 with the issuance of the first Drug Price Control Order based on the recommendations of the Haiti Committee. The DPCO was subsequently revised in 1987 and in 1995, leading to reduction of the scope of controls. Currently, there is no price control on about 75% of the retail pharma market. As for the balance of the retail market, the government fixes the prices to the consumer under the provisions of the drug price control order (DPCO) of 1995. Currently, 74 bulk drugs are in Schedule 1 of the DPCO?95 and their formulations are under price control.
  
  What are the criteria for bringing drugs under the DPCO regime?
  At present, the criteria for bringing a drug under control is the essential nature of the drug. The World Health Organization (WHO) defines essential medicines are those that satisfy the priority health care needs of the population. The National List of Essential Medicines contains 354 drugs, out of which 74 drugs were under price control. The Supreme Court, however, passed a judgement in 2003 directing the government to ensure that all essential and life saving drugs do not fall out of price control.
  
  What are the salient features of new drug policy?
  The key feature will be the pricing policy. The draft pricing policy states that all 354 drugs on the National List of Essential Medicines will be under price control. A cost based pricing structure has been mooted by the expert committee. While the earlier policy allowed 100% margin in maximum allowable post manufacturing expenses (MAPE), the new policy is likely to allow MAPE of 150% with an additional 50% margin for companies that have R&D activities meeting the certain gold standards by the Pharmaceutical Research and Development Committee under the Council of Scientific and Industrial Research. The draft policy is also states that drugs of patented products will be subjected to price negotiations and only indigenously developed drugs will be out of price control. Other products that are likely to be out of the price control ambit are those that are sold directly to hospitals and healthcare institutions, those that are priced at Rs. 1 or below and vaccines and other
 biological products. 
  
  Unquote
  The above should be of interest to all. 
  The Delhi Society for Promotion of Rational Use of Drugs (DSPRUD) had occasion to see the Draft Drug Policy and comment on it. Some of the comments made by DSPRUD are reproduced below:
   
  Comments
                      General:
  
      The draft has no reference to the concept of rational use of drugs and how to promote rational use of drugs. It is desirable that the paper commits the government to rational use of drugs and ways to promote its rational use. Rational Use of Drugs needs to be promoted by multi-pronged strategies comprising training of health professionals (including doctors, pharmacists, nurses and other para medical health workers) and creating awareness amongst the community and the patients about rational use of drugs and consequences of irrational use of drugs, curriculum revision of medical education to include rational use of drugs concepts etc. The Delhi Policy is a good example in this effort (Delhi, the first state to have a comprehensive state drug policy).
  
                Others  
        
      The Draft Policy while strengthening the regulation does not delineate that granting a license to a new drug would be based on country?s needs and priorities and rational selection and how to deal with the skewed production profile of the industry. There has been no mention about weeding of irrational drug combinations available in the market.  
      
      There should be a commitment in the policy document about the date by which an effective NDA would be set up.


      3.   Pharmacists have a crucial role in dispensing of medicines in the public health system. The major lacuna in the present system is the shortage 
of qualified pharmacists both in the public health system and in the  
community pharmacies. The draft policy should address as to how              shortages of qualified pharmacists could be overcome in a given time              span.
     4.   The Policy envisages bulk procurement of drugs as one way of ensuring competitive prices. Examples of Delhi and Tamil Nadu have 
demonstrably shown the success of bulk/pooled procurement. In both 
the examples drugs are procured only by there generic names. The 
reference to ?preferably all generic names? should be deleted. In the 
procurement of drugs there should be a level playing field and there 
should be no preference given to public sector units. If at all preferential 
pricing is to be extended to public sector units, the subsidy should not 
be from the health budget (where the provision is already grossly 
inadequate) but from the industry or the department which controls the 
public sector unit.
     5.    There is need to improve the quality of drugs produced in the public sector units and there should be a commitment in this direction in the policy statement. All public sector units should practice stringent quality standards and should have all the necessary wherewithal like testing 
equipment, quality staff and the like ? so that the highest quality 
standards can be maintained. 
     6.    The policy should spell out strategy for good supply chain management and the logistics of ensuring supplying drugs to remote areas keeping the geographic features of the country. 

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  We are awaiting the draft policy to see to what extent the comments of DSPRUD have been included. If and when the draft policy is publicized, an opportunity should be available to all stakeholders to comment on the policy. The above comments of DSPRUD would facilitate an informed discussion on the subject.
     
R. Parameswar
President
Delhi Society for Promotion of Rational Use of Drugs
DSPRUD <dsprud2005@yahoo.com>