* On the issue of sub-standard drugs in the market .* E A S Sarma
* On the issue of sub-standard drugs in the market .*
E A S Sarma
Former Secretary to the Government of India
To
Shri Rajesh Bhushan
Union Health Secretary
Dear Shri Rajesh Bhushan,
I find that the US Federal Drug Regulatory authority's inspectors routinely conducting surprise inspection of India pharma units' manufacturing facilities. One such visit has been reported today in https://economictimes.indiatimes.com/prime/pharma-and-healthcare/data-integrity-woes-have-come-back-to-haunt-indian-pharma-how-can-it-deal-with-the-usfdas-glare/primearticleshow/99712904.cms
How is it that a foreign regulatory authority's representatives are allowed to visit Indian pharma units' premises without any notice to the domestic drugs regulator's office? Why is the domestic regulator reluctant to conduct similar surprise inspections to make sure that our pharma units conform to global standards of safety?
The Parliamentary Committee on your Ministry, in their 59th Report presented to the Parliament on 8-5-2012, made some far-reaching recommendations on reforming the office of the drug controller. In particular, the following observations of that Committee are important.
"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured. Taking strong exception to this continued neglect of the poor and hapless patient, the Committee recommends that the Mission Statement of CDSCO be formulated forthwith to convey in very unambiguous terms that the organization is solely meant for public health. (Para 2.2) The Committee notes with serious concern that CDSCO is substantially understaffed. Of the 327 sanctioned posts, only 124 are occupied. At this rate, what would be the fate of 1,045 additional posts that have been proposed is a moot point. If the manpower requirement of the CDSCO does not correspond with their volume of work, naturally, such shortage of staff strains the ability of the CDSCO to discharge its assigned functions efficiently. This shortcoming needs to be addressed quickly. Consideration can also be given to employ medically qualified persons as Consultants/Advisers (on the pattern of Planning Commission) at suitable rank"
I am not sure whether CDSCO's focus has since shifted from the promotion of the pharma industry to safeguard the interests of users of drugs and whether the organisation has been suitably strengthened and professionalised. The recent unsavoury instances of exported Indian drugs being found substandard by overseas agencies should cause concern to your Ministry.
Had the domestic regulator devoted adequate attention to the Indian pharma units conforming to global norms of safety, the external regulators would not have found it necessary to depute their representatives to inspect them frequently.
From what I observed about the pharma units in and around Visakhapatnam, they are callous regarding the safety of the workers, totally unconcerned about the toxic pollution they cause and the political clout they enjoy that allows them to go scot-free every time a fatal accident takes place. There is not a day when accidents do not take place here and workers lose lives. That itself shows the fragility of domestic regulation of the industry in general and regulation of the pharma industry in particular.
I hope your Ministry, in collaboration with the Ministry of Chemicals & Fertilisers (Dept of Pharmaceuticals), takes such measures that enhance the credibility of the pharma industry in the eyes of the public.
Regards,
Yours sincerely,
E A S Sarma
Visakhapatnam
25-4-2023
Sir gud morning do u have Mr Sarma's No. Thanks
EAS Sarma former Secy Visakhapatnam
Thanks sir rgds